WO2024224329A1

WO2024224329A1 - Compositions comprising a cannabinoid and a non-cannabinoid, non-terpene compound

Info

Publication number: WO2024224329A1
Application number: PCT/IB2024/054041
Authority: WO
Inventors: Noa Raz; Aharon Eyal; Iso HELLER
Original assignee: Buzzelet Development and Technologies Ltd
Current assignee: Buzzelet Development and Technologies Ltd
Priority date: 2023-04-28
Filing date: 2024-04-25
Publication date: 2024-10-31
Anticipated expiration: 2025-10-28

Abstract

Provided are pharmaceutical compositions comprising at least one cannabinoid, at least one non-cannabinoid, non-terpene compound, such as an active pharmaceutical ingredient (API) or a nutraceutical and a pharmaceutically acceptable carrier and uses thereof in therapy, such as in treatment of a neurodevelopmental disorder, a neurodegenerative disorder or acute pain in a subject.

Description

COMPOSITIONS COMPRISING A CANNABINOID AND A NON-CANNABINOID, NON-TERPENE COMPOUND Cross-Reference to Related Applications [001] The present application gains priority from U.S Provisional Patent Applications having Serial No.63/462,547 filed April 28, 2023; 63/464,641 filed May 8, 2023; and 63/600, 747 filed November 20, 2023, all of which are incorporated by reference as if fully set-forth herein. Field of the Invention [002] The field of art to which this invention generally pertains is pharmaceutical compositions, and more specifically to pharmaceutical compositions comprising a cannabinoid; a non-cannabinoid, non-terpene compound and a pharmaceutically-acceptable carrier, and uses thereof in therapy. Background of the invention [003] Cannabinoids are compounds found in the Cannabis sativa plant and which are known to have a wide range of uses in therapy. [004] There is an unmet need for improved therapeutic treatments using cannabinoids. [005] Autism spectrum disorder (ASD) is a group of complex neurodevelopmental disorders, defined by the American Psychiatric Association as a complex neurodevelopmental disorder characterized by a set of core symptoms including persistent deficits in social communication and social interaction across multiple contexts and restricted, repetitive patterns of behavior, interests and activities. These symptoms must be present in the early developmental period and produce clinically significant developmental impairment in social, occupational or other important areas of current functioning. [006] The exact cause of ASD is unclear, but a combination of different risk factors and genetic and environmental factors is assumed. The conventional perspective of ASD symptoms suggests that ASD is a genetic disorder that involves a complex genetic background. Several research directions support the belief that a combination of complex neurobiological, environmental, immunological and genetic factors is crucial in the etiology of ASD. Additionally, proinflammatory cytokines secreted by several types of different cells contribute to the pathogenesis of neuroinflammation. [007] Many patients with ASD have associated medical disorders such as anxiety, sleep disorders, metabolic disorders, eating disorders and gastrointestinal (GI) problems that have a significant impact on the quality of patients and their caregiver’s lives. Up to 80% of children with ASD also have sleep disorders including prolonged sleep-onset latency, extended night-awakenings, and early morning awakenings. [008] There is no established pharmacological treatment for the core symptoms of ASD. Risperidone and aripiprazole have been approved by the U.S. Food and Drug Administration (FDA) to treat comorbid irritability but these medications often cause obesity and metabolic syndrome. [009] Educational, psychosocial, and pharmacologic interventions appear to improve associated psychiatric symptoms and functioning in people with ASD, especially if applied at early developmental stages. However, few treatments are efficacious for the core symptoms of ASD, with only early and intensive treatments revealing improvements on dyadic and/or social interaction deficits. [0010] In view of the known disadvantages of existing treatments for ASD, many patients with ASD seek alternative medicine and non-medicine treatment strategies. For example, some 25% of people with ASD use dietary interventions such as restrictive diets (the most common being gluten- and casein-free diets) and/or nutritional supplements such as vitamins, minerals, amino acids, omega-3, and herbal compounds. However, results on the efficacy of dietary interventions in ASD are still controversial. This may be because authors of most studies assess dietary interventions as a whole, without differentiating specific interventions, or assess treatment response as a global measure, without focusing on specific ASD core or associated symptoms or clinical domains. [0011] There is thus an unmet need for improved therapeutic treatments for neurodevelopmental disorders such as ASD and neurodegenerative disorders. [0012] Acute pain is pain having sudden onset and specific cause. [0013] Known treatment of acute pain, such as acute radicular pain, is mostly based on opioid treatment, either alone or in combination with other analgesic drugs. However, while use of opioids results in potent analgesia, their use is associated with notable risks, including dependence and overdose. [0014] There is thus an unmet need for improved methods of treatment of acute pain, which are devoid of at least some of the disadvantages of the prior art methods. Summary of the Invention [0015] According to an aspect of some embodiments of the present invention, there is provided a pharmaceutical composition comprising at least one cannabinoid; at least one non- cannabinoid, non-terpene compound; and a pharmaceutically-acceptable carrier. [0016] According to an aspect of some embodiments of the present invention, there is provided a composition comprising at least one cannabinoid, at least one non-cannabinoid compound selected from the group consisting of anti-oxidants, anti-inflammatory agents, nutraceuticals and combinations thereof, wherein the non-cannabinoid compound has a solubility in medium-chain triglycerides (MCT) of at least 10 microgram (mcg)/ml at 25 ^oC; and a non-terpene, non-cannabinoid carrier. Further provided are uses of the composition in the treatment of neurodevelopmental disorders and neurodegenerative disorders and methods of treatment of neurodevelopmental disorders and neurodegenerative disorders using the composition. [0017] According to a further aspect of some embodiments of the present invention, there is provided a composition comprising at least one cannabinoid for co-administration with at least one non-cannabinoid compound selected from the group consisting of anti-oxidants, anti- inflammatory agents, nutraceuticals and combinations thereof, wherein said non-cannabinoid compound has a solubility in medium-chain triglycerides (MCT) of at least 10 mcg/ml at 25 ^oC, for use in the treatment of a neurodevelopmental disorder or a neurodegenerative disorder. [0018] According to a further aspect of some embodiments of the present invention, there is provided a method for the treatment of a neurodevelopmental disorder or a neurodegenerative disorder in a subject in need thereof, the method comprising administering to the subject a composition comprising at least one cannabinoid, at least one non-cannabinoid compound selected from the group consisting of anti-oxidants, anti-inflammatory agents, nutraceuticals and combinations thereof, wherein the non-cannabinoid compound has a solubility in medium- chain triglycerides (MCT) of at least 10 mcg/ml at 25 ^oC; and a non-terpene, non-cannabinoid carrier. [0019] According to a further aspect of some embodiments of the present invention, there is provided a method for treating acute pain in a subject in need thereof, the method comprising administering to the subject between 11 and 40 mg THC and between 11 and 40 mg CBD within a 24-hour period measured from commencement of treatment and no greater than 90% of the dose of a non-cannabis analgesic required to provide the same effect in the subject in the absence of THC and CBD. [0020] According to a further aspect of some embodiments of the present invention, there is provided THC for coadministration with CBD for use in treating acute pain, wherein THC is for administration to the subject at between 11 and 40 mg and CBD is for administration to the subject at between 11 and 40 mg CBD within a 24 period measured from commencement of treatment and no greater than about 90% of the dose of a non-cannabis analgesic required to provide the same effect in the subject in the absence of THC and CBD. Brief description of the figures [0021] Some embodiments of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments of the invention may be practiced. The figures are for the purpose of illustrative discussion and no attempt is made to show structural details of an embodiment in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale. In the Figures: [0022] Fig.1 is a line graph showing opioid use over time as measured by total number of effective pushes on a patient-administered morphine pump in subjects receiving high doses (20 mg) of each of THC and CBD (triangle) as compared to those receiving low doses (10 mg) of each of THC and CBD (square) or placebo (circle). Detailed description of the invention [0023] The present invention provides pharmaceutical compositions comprising a cannabinoid; a non-cannabinoid, non-terpene compound; and a pharmaceutically-acceptable carrier, and uses thereof in therapy. [0024] The compositions of the present invention provide improved methods of treatment, such as improved treatment of conditions of the nervous system, such as by reducing doses of the cannabinoid and/or of the non-cannabinoid, non-terpene compound required to achieve the same effect as that obtained with use of either the cannabinoid or the non-cannabinoid, non- terpene compound in the absence of the other, which may be particularly important in the case of drugs having significant side-effects or which are addictive. The combined administration may further shorten onset time and/or extend duration of the therapeutic effect due to the different pharmacokinetics of the two drugs. [0025] Compositions comprising both components in a single dosage form have further been found to improve patient compliance. [0026] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for describing particular embodiments only and is not intended to be limiting of the invention. [0027] As used herein, the term “active pharmaceutical ingredient” refers to a component other than a cannabinoid or a terpene that provides pharmacological activity or other direct effect in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of a living being. [0028] As used herein the term “treating” includes preventing, curing, ameliorating, mitigating, and reducing the instances or severity of a condition or a symptom thereof. [0029] As used herein, the term "administering" includes any mode of administration, such as oral, subcutaneous, sublingual, transmucosal, parenteral, intravenous, intra-arterial, buccal, sublingual, topical, vaginal, rectal, ophthalmic, otic, nasal, inhaled, intramuscular, intraosseous, intrathecal, and transdermal, or combinations thereof. "Administering" can also include providing a different compound that when ingested or delivered as above will necessarily transform into the compound that is desired to be administered, this type of “different compound” is often being referred to as a “Prodrug”. "Administering" can also include prescribing or filling a prescription for a dosage form comprising a particular compound. "Administering" can also include providing directions to carry out a method involving a particular compound or a dosage form comprising the compound or compounds. [0030] As used herein, the term "therapeutically effective amount" means the amount of an active substance that, when administered to a subject for treating a disease, disorder, or other undesirable medical condition, is sufficient to have a beneficial effect with respect to that disease, disorder, or condition. The therapeutically effective amount will vary depending on the chemical identity and formulation form of the active substance, the disease or condition and its severity, and the age, weight, and other relevant characteristics of the subject to be treated. Determining the therapeutically effective amount of a given active substance is within the ordinary skill of the art and typically requires no more than routine experimentation. [0031] As used herein, the term “commencement of treatment” refers to the time at which THC and CBD are administered, or to administration of a first one of THC and CBD, when THC and CBD are not administered substantially simultaneously or in a single dosage form. [0032] As used herein, “radicular pain” refers to a type of pain that radiates from a compressed or inflamed nerve root. [0033] Unless indicated otherwise, the term “cannabinoid” as used herein refers to a compound that affects the endocannabinoid system and includes the decarboxylated form of the compound, the acid form of the compound, or combinations thereof. Cannabinoids are agonists or antagonists to receptors in the endocannabinoid system. As used herein, cannabinoid may comprise an endogenous cannabinoid, also known as an endocannabinoid or an exogenous cannabinoid, extracted from a cannabis plant, from a hemp plant or manufactured artificially. [0034] As used herein, the term “CBD” refers to CBDa (cannabidiolic acid) and/or to CBD (cannabidiol) unless indicated otherwise. As used herein, the term “THC” refers to THCa (tetrahydrocannabiniolic acid) and/or to THC (tetrahydrocannabiniol) unless indicated otherwise. As used herein, the term “CBG” refers to CBGa (cannabigerolic acid) and/or to CBG (cannabigerol) unless indicated otherwise. As used herein, the term “CBN” refers to CBNa (Cannabinolic acid) and/or to CBN (cannabinol) unless indicated otherwise. As used herein, the term “CBC” refers to CBCa (cannabichromenic acid) and/or to CBC (Cannabichromene) unless indicated otherwise. As used herein, the term “CBL” refers to CBLa (Cannabicycol acid) and/or to CBL (Cannabicyclol) unless indicated otherwise. As used herein, the term “THCV” refers to THCVa (tetrahydrocannabivarin acid) and/or to THCV (tetrahydrocannabivarin) unless indicated otherwise. As used herein, the term “CBDV” refers to CBDVa (cannabigerovarin acid) and/or to CBDV (cannabidivarin) unless indicated otherwise. [0035] As used herein, the term “terpene” refers to both terpenes and terpenoids. [0036] As used herein, the term “anti-oxidant” refers to a compound that prevents, inhibits or reduces oxidative damage, either directly or indirectly. [0037] As used herein, the term “anti-inflammatory agent” refers to an agent that prevents, inhibits or reduces inflammation, either directly or indirectly. [0038] As used herein, the term “nutraceutical” refers to a food or a component thereof that provides medical or health benefits, including the prevention or treatment of disease. Nutraceuticals include vitamins, minerals, botanicals, herbs, and dietary substances. [0039] As used herein, the term “intellectual disability” refers to a deficit in general mental abilities, which affects the ability of a subject to process information, learn or retain information, think critically or abstractly and solve problems. [0040] As used herein, the term “learning disability” refers to a disorder that affects the ability to perform mathematical calculations, coordinate movements or direct attention. [0041] As used herein, the term “communication disorder” refers to a disorder that affects the ability of a subject to comprehend, detect, or apply language and speech to effectively engage in dialogue with others. [0042] As used herein, the term “conduct disorder” refers to a mental disorder, diagnosed in childhood or adolescence, that presents itself through a repetitive and persistent pattern of behaviour that includes theft, lies, physical violence, and that may lead to destruction and reckless breaking of rules in which the basic rights of others or major age-appropriate norms are violated. [0043] Unless indicated otherwise, percent is weight percent and ratio is weight/weight ratio. Unless indicated otherwise, weight ratio means the ratio between weight content. [0044] As used in the description of the invention and the appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. [0045] Unless otherwise indicated, all numbers expressing quantities of ingredients, reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should be construed in light of the number of significant digits and ordinary rounding approaches. [0046] As used herein, when a numerical value is preceded by the term ”about”, the term “about” is intended to indicate ±10% of that value. [0047] Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Every numerical range given throughout this specification will include every narrower numerical range that falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein. [0048] As used herein, the terms “comprising”, “including”, "having" and grammatical variants thereof are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof. These terms encompass the terms "consisting of" and "consisting essentially of". [0049] Additional advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. [0050] The particulars shown herein are by way of example and for purposes of illustrative discussion of the various embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. [0051] The present invention will now be described by reference to more detailed embodiments. This invention may, however, be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. [0052] According to an aspect of some embodiments of the present invention, there is provided a composition comprising at least one cannabinoid; at least one non-cannabinoid, non- terpene compound; and a pharmaceutically-acceptable carrier. According to some embodiments, the composition comprises a dose of between about 1 mg and about 100 mg of the at least one cannabinoid and a dose of between about 1 mg and about 100 mg of the at least one API. According to some embodiments, the dose of the cannabinoid and/or of the API is about 1 mg, about 5 mg, about 10 mg, about 15 mg, about 20 mg, about 25 mg, about 30 mg, about 35 mg, about 40 mg, about 45 mg, about 50 mg, about 55 mg, about 60 mg, about 65 mg, about 70 mg, about 75 mg, about 80 mg, about 85 mg, about 90 mg, about 95 mg or about 100 mg. [0053] According to some embodiments, the composition further comprises at least one terpene selected from the group consisting of bisabolol, borneol, camphor, carene, caryophyllene, eucalyptol, geraniol, humulene, myrcene, limonene, linalool, nerolidol, ocimene, pinene, sabine, terpineol and combinations thereof. [0054] According to some embodiments, the non-cannabinoid, non-terpene compound is an active pharmaceutical ingredient (API). [0055] According to some embodiments, the dose of the API is at least 10% (such as 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 99%) smaller than the dose required to achieve the same effect in the absence of the cannabinoid. [0056] According to some embodiments, the dose of the cannabinoid is at least 10% (such as 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 99%) smaller than the dose required to achieve the same effect in the absence of the API. [0057] According to some embodiments, the API modulates the effect of the cannabinoid. According to some such embodiments, the API modulates the interaction between the cannabinoid and a receptor of the endocannabinoid system. [0058] According to some embodiments, the cannabinoid modulates the effect of the non- cannabinoid API. [0059] According to some embodiments, the at least one cannabinoid is selected from the group consisting of tetrahydrocannabiniol in acid or decarboxylated form (THCa or THC, respectively), cannabidiol in acid or decarboxylated form (CBDa or CBD, respectively), cannabigerol in acid or decarboxylated form (CBGa or CBG, respectively), cannabichromene in acid or decarboxylated form (CBCa or CBC, respectively) tetrahydrocannabivarin in acid or decarboxylated form (THCVa or THCV, respectively), Cannabidivarin in acid or decarboxylated form (CBDVa or CBDV respectively) and cannabinol in acid or decarboxylated form (CBNa or CBN, respectively), and combinations thereof. [0060] According to some embodiments, the API is selected from the group consisting of an analgesic drug, an anti-inflammatory drug, a drug affecting serotonin levels in serum or plasma, a central nervous system (CNS) stimulant, a drug for treating a sleep disorder, a dopamine agonist or precursor thereof, an antidepressant, an antipsychotic drug, an anti- spasmodic drug, a bisphosphonate, a dopamine antagonist, a central adrenergic inhibitor, an aminosalicylate, an anti-oxidant, an ergot alkaloid, an anesthetic and combinations thereof. [0061] According to some embodiments, the API comprises an analgesic drug. According to some such embodiments, the cannabinoid comprises THC. [0062] According to some embodiments, the analgesic drug is selected from the group consisting of a natural or synthetic opioid, a centrally acting non-opioid analgesic, a gabapentinoid, an anti-inflammatory drug and combinations thereof. [0063] According to some embodiments, the natural opioid is selected from the group consisting of opium, morphine, codeine, heroin and combinations thereof. [0064] According to some embodiments, the synthetic opioid is selected from the group consisting of tramadol hydrochloride, dextromethorphan, dextropropoxyphene, loperamide, hydocodone, oxycodone, oxymorphone, meperidine, methadone, fentanyl, carfenatyl and combinations thereof. [0065] According to some embodiments, the centrally acting non-opioid analgesic is selected from the group consisting of paracetamol (also known as acetaminophen), nefopam, flupirtine, dipyrone (also known as metamizole) and combinations thereof. [0066] According to some embodiments, the gabapentinoid is selected from the group consisting of pregabalin, gabapentin, microgabalin, phenibut and combinations thereof. According to some embodiments, the gabapentinoid is for use in treating neuropathic pain. [0067] According to some embodiments, the anesthetic drug is used to provide local anesthesia during to or following surgery. According to some embodiments, the anesthetic drug is selected from the group consisting of lidocaine, prilocaine, bupivacaine, propofol, etomidate and ketamine. [0068] According to some embodiments, the API comprises an anti-inflammatory drug. According to some such embodiments, the cannabinoid comprises CBD. [0069] According to some embodiments, the anti-inflammatory drug is selected from the group consisting of a steroid, a non-steroidal anti-inflammatory drug (NSAID), a biological anti-inflammatory drug and combinations thereof. [0070] According to some embodiments, the NSAID is selected from the group consisting of ibuprofen, acetylsalicylic acid (aspirin), naproxen, diclofenac, acelofenac, celecoxib, mefenamic acid, etoricoxib, indomethacin, etodolac and combinations thereof. [0071] According to some embodiments, the steroid is selected from the group consisting of hydrocortisone, cortisone, prednisone, prednisolone, methylprednisolone, dexamethasone, betamethasone, triamcinolone, deflazacort, fludrocortisone acetate, deoxycorticosterone acetate, aldosterone, beclomethasone, fluticasome, budesonide and combinations thereof. [0072] According to some embodiments, the biological anti-inflammatory drug is selected from the group consisting of a Tumor Necrosis Factor (TNF)-α inhibitor, a B-cell inhibitor, an interleukin inhibitor, a Selective Co-Stimuloation Modulator and combinations thereof. [0073] According to some embodiments, the API comprises a drug affecting serotonin levels in serum or plasma, selected from the group consisting of a Selective Serotonin Reuptake Inhibitor (SSRI) and a Serotonin and Norepinephrine Reuptake Inhibitor (SNRI) such as duloxetine. According to some such embodiments, the cannabinoid comprises CBD. [0074] According to some embodiments, the SSRI is selected from the group consisting of citalopram, dapoxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vortioxetine and combinations thereof. [0075] According to some embodiments, the SSRI is an anti-migraine agent, such as triptan. [0076] According to some embodiments, the SNRI is selected from the group consisting of duloxetine, desvenlafaxine, venlafaxine, milnacipran, levomilnacipran and combinations thereof. [0077] According to some embodiments, the API comprises a central nervous system (CNS) stimulant. According to some such embodiments, the cannabinoid comprises CBD and/or or THC. [0078] According to some embodiments, the central nervous system stimulant is selected from the group consisting of methylphenidate hydrochloride, an amphetamine, armodafinil, atomoxetine, cocaine, modafinil, oxybate, pitolisant, solriamfetol, caffeine and combinations thereof. [0079] According to some embodiments, the API comprises a drug for treating a sleep disorder. According to some such embodiments, the cannabinoid is selected from the group consisting of THC, CBD and a combination thereof. [0080] According to some embodiments, the drug for treating a sleep disorder is selected from the group consisting of a benzodiazepine, a non-benzodiazepine hypnotic, a melatonin receptor agonist, an antispasmodic, an antinarcoleptic, an antidepressant, an orexin receptor antagonist and combinations thereof. [0081] According to some embodiments, the benzodiazepine is selected from the group consisting of alprazolam, clobazam, clonazepam, diazepam, estazolam, lorazepam, orazepam, temazepm and combinations thereof. [0082] According to some embodiments, the non-benzodiazepine hypnotic is selected from the group consisting of eszopiclone, zaleplon, zolpidem, zopiclone, zopiclone, diphenhydramine, ramelteron, or a herbal sedative such as Valeriana officinalis and combinations thereof. [0083] According to some embodiments, the melatonin receptor agonist comprises melatonin and/or ramelteon. [0084] According to some embodiments, the antispasmodic is selected from the group consisting of carbamazepine, gabapentin enacarbil, pregabalin, valproate and combinations thereof. [0085] According to some embodiments, the antinarcoleptic is selected from the group consisting of methylphenidate, modafinil, pitolisant, sodium oxybate and combinations thereof. [0086] According to some embodiments, the antidepressant is selected from the group consisting of mirtazapine, quetiapine and combinations thereof. [0087] According to some embodiments, the orexin receptor antagonist is selected from the group consisting of daridorexant, lemborexant, suvorexant and combinations thereof. [0088] According to some embodiments, the API comprises a dopamine agonist or precursor thereof selected from the group consisting of gabapentin enacarbil, levodopa, pramipexole, ropinirole, rotigotine and combinations thereof. [0089] According to some embodiments, the API comprises an anti-depressant. According to some embodiments, the antidepressant is selected from the group consisting of an SSRI, an SNRI, a tricyclic antidepressant, a GABA-modulator, a monoamine oxidase inhibitor and combinations thereof. According to some such embodiments, the monoamine oxidase inhibitor is selected from the group consisting of isocarboxazid, phenelzine, selegiline, tranylcypromine, moclobemide and combinations thereof. According to some such embodiments, the GABA- modulator is gabapentin. [0090] According to some embodiments, the non-cannabinoid API comprises an antipsychotic drug. According to some such embodiments, the cannabinoid comprises CBD. [0091] According to some embodiments, the antipsychotic drug is selected from the group consisting of a typical antipsychotic, an atypical antipsychotic and a combination thereof. [0092] According to some embodiments, the typical antipsychotic comprises an SRNI or a tricyclic antidepressant. According to some such embodiments, the tricylclic antidepressant is selected from the group consisting of amitriptyline, desipramine, clomipramine and combinations thereof. [0093] According to some embodiments, the typical antipsychotic is selected from the group consisting of chlorpromazine, clozapine, droperidol, flupenthixol, fluphenazine, haloperidol, loxapine, perphenazine, pimozide, trifluoperazine, thiothixene, zuclopenthixol and combinations thereof. [0094] According to some embodiments, the atypical antipsychotic is selected from the group consisting of risperidone, quetiapine, olanzapine, ziprasidone, paliperidone, aripiprazole, clozapine and combinations thereof. According to some such embodiments, the cannabinoid comprises CBD. [0095] According to some embodiments, the API comprises an anti-spasmodic drug. According to some such embodiments, the cannabinoid comprises THC. [0096] According to some embodiments, the anti-spasmodic drug is selected from the group consisting of a smooth muscle relaxant and an anticholinergic agent. [0097] According to some embodiments, the smooth muscle relaxant is selected from the group consisting of alverine, mebeverine, peppermint oil and anticholinergic combinations thereof. [0098] According to some embodiments, the anticholinergic agent is selected from the group consisting of dicycloverine, cyclobenzaprine, hyoscine, atropine, propantheline and combinations thereof. According to some such embodiments, the cannabinoid comprises THC. [0099] According to some embodiments, the API comprises a bisphosphonate. [00100] According to some embodiments, the bisphosphonate is selected from the group consisting of alendronate, risedronate, ibandronate, pamidronate, zoledronic acid and combinations thereof. [00101] According to some embodiments, the API comprises a dopamine antagonist. According to some such embodiments, the dopamine antagonist is selected from the group consisting of haloperidol, tetrabenzine, fluphenazine, risperidone, pimozide and combinations thereof. [00102] According to some embodiments, the aminosalicylate is mesalazine. [00103] According to some embodiments, the ergot alkaloid is selected from the group consisting of dihyroergotamine, ergotamine and combinations thereof. [00104] According to an aspect of some embodiments of the present invention, there is provided a composition as disclosed herein for use in treating agitation or anxiety in a subject in need thereof, wherein the cannabinoid is selected from the group consisting of CBD, CBG, CBD and combinations thereof, and wherein the API comprises an antipsychotic agent and/or a benzodiazepin. According to some such embodiments, the composition further comprises at least one terpene selected from the group consisting of pinene, myrcene, limonene, linalool, eucalyptol, terpineol, borneol, caryophyllene, nerolidol, bisabolol and combinations thereof. According to some embodiments, the subject has been diagnosed with dementia or with autism spectrum disorder (ASD). [00105] According to an aspect of some embodiments of the present invention, there is provided a composition as disclosed herein for use in treating Tourette syndrome in a subject in need thereof, wherein the cannabinoid is selected from the group consisting of THC, CBD and combinations thereof and wherein the API is selected from the group consisting of a dopamine antagonist, an atypical antipsychotic, a central adrenergic inhibitor (such as clonidine), an antidepressant (such as fluoxetine), a benzamide and combinations thereof. According to some such embodiments, the composition further comprises at least one terpene selected from the group consisting of pinene, myrcene, limonene, linalool, eucalyptol, terpineol, borneol, caryophyllene, nerolidol and combinations thereof. [00106] According to an aspect of some embodiments of the present invention, there is provided a composition as disclosed herein for use in treating endometriosis in a subject in need thereof wherein the cannabinoid is selected from the group consisting of THC and/or CBD (for providing analgesic and anti-inflammatory effects) and wherein the API is selected from the group consisting of a hormone (such as gonadotropin-releasing hormone, estrogen, progestin, progesterone and combinations thereof, estrogen and progestin (optionally provided in the form of an oral contraceptive), danaol; an analgesic (such as an NSAID) and combinations thereof. According to some such embodiments, the composition further comprises at least one terpene selected from the group consisting of pinene, myrcene, linalool, limonene, sabinene, terpineol, borneol, geraniol, caryophyllene, nerolidol, bisabolol, humulene and combinations thereof. [00107] According to an aspect of some embodiments of the present invention, there is provided a composition as disclosed herein for use in treating fibromyalgia in a subject in need thereof, wherein the cannabinoid is selected from the group consisting of THC and/or CBD and wherein the API is selected from the group consisting of an analgesic, an antidepressant such as a typical antidepressant, an anticonvulsant and combinations thereof. According to some such embodiments, the API comprises a steroid and/or an NSAID. According to some such embodiments, the composition further comprises at least one terpene selected from the group consisting of pinene, myrcene, linalool, limonene, sabinene, terpineol, borneol, geraniol, caryophyllene, nerolidol, bisabolol, humulene and combinations thereof. [00108] According to an aspect of some embodiments of the present invention, there is provided a composition as disclosed herein for use in treating osteoarthritis in a subject in need thereof, wherein the cannabinoid is selected from the group consisting of THC, CBD, CBG, CBD and combinations thereof, and wherein the API is selected from the group consisting of an anti-inflammatory analgesic, such as a steroid, an NSAID or an SNRI. According to some such embodiments, the composition further comprises at least one terpene selected from the group consisting of pinene, myrcene, linalool, sabinene, terpineol, borneol, geraniol, caryophyllene, nerolidol, humulene, limonene and combinations thereof. [00109] According to an aspect of some embodiments of the present invention, there is provided a composition as disclosed herein for use in treating Amyotrophic Lateral Sclerosis (ALS) in a subject in need thereof, wherein the cannabinoid is selected from the group consisting of THC, CBG and a combination thereof, and wherein the API comprises riluzole. According to some such embodiments, the composition further comprises at least one terpene selected from the group consisting of linalool, limonene, eucalyptol, myrcene, caryophyllene, linalool, borneol, sabinene, terpineol, pinene, ocimene, bisabolol and combinations thereof. [00110] According to an aspect of some embodiments of the present invention, there is provided a composition as disclosed herein for use in treating a symptom of multiple sclerosis (MS) in a subject in need thereof, wherein the cannabinoid is selected from the group consisting of THC, CBD, CBG and combinations thereof and wherein the API comprises an anti- inflammatory agent, such as a steroid, for example prednisone or methylprednisolone. According to some such embodiments, the at least one terpene selected from the group consisting of pinene, myrcene, caryophyllene, limonene, eucalyptol, linalool, humulene, borneol, sabinene, terpineol, geraniol, nerolidol, bisabolol and combinations thereof. [00111] According to an aspect of some embodiments of the present invention, there is provided a composition as disclosed herein for use in treating Huntington’s disease in a subject in need thereof, wherein the cannabinoid is selected from the group consisting of THC, CBD, CBG and combinations thereof and wherein the API is selected from the group consisting of an antipsychotic drug (such as levodopa, haloperidol or fluphenazine), an antidepressant and an antidyskinetic drug (such as amantadine or tetrabenzine). According to some such embodiments, the composition further comprises at least one terpene selected from the group consisting of linalool,s limonene, pinene, myrcene, humulene, borneol, sabinene, terpineol, caryophyllene, humulene and combinations thereof. [00112] According to an aspect of some embodiments of the present invention, there is provided a composition as disclosed herein for use in treating osteoporosis in a subject in need thereof, wherein the cannabinoid comprises CBD and wherein the API is selected from the group consisting of a bisphosphonate, an analgesic and a combination thereof. According to some such embodiments, the composition further comprises at least one terpene selected from the group consisting of caryophyllene, humulene, carene, camphor, pinene, borneol, limonene, nerolidol and combinations thereof. [00113] According to an aspect of some embodiments of the present invention, there is provided a composition as disclosed herein for use in treating cystic fibrosis in a subject in need thereof, wherein the cannabinoid is selected from the group consisting of CBD, THC and a combination thereof and wherein the API is selected from the group consisting of an antibiotic, a mucolytic (such as hypertonic saline, mannitol, dornase alfa and combinations thereof), a bronchodilator (such as albuterol, levalbuterol hydrochloride and a combination thereof), an anti-inflammatory drug and combinations thereof. According to some such embodiments, the composition further comprises at least one terpene selected from the group consisting of pinene, limonene, eucalyptol, caryophyllene, sabinene, geraniol, bisabolol, humulene and combinations thereof. [00114] According to an aspect of some embodiments of the present invention, there is provided a composition as disclosed herein for use in treating migraine in a subject in need thereof, wherein the cannabinoid is selected from the group consisting of THC, CBC and a combination thereof, and wherein the API is selected from the group consisting of an analgesic, an SSRI (such as triptan), an ergot alkaloid and combinations thereof. According to some such embodiments, the composition further comprises at least one terpene selected from the group consisting of caryophyllene, ocimene, terpineol, linalool, limonene, myrcene, borneol, sabinene, pinene, nerolidol, bisabolol and combinations thereof. [00115] According to an aspect of some embodiments of the present invention, there is provided a composition as disclosed herein for use in treating phantom pains in a subject in need thereof, wherein the cannabinoid comprises THC and wherein the API is selected from the group consisting of an NSAID, an antidepressant, an antispasmodic, a beta blocker, a muscle relaxant and combinations thereof. According to some such embodiments, the composition further comprises at least one terpene selected from the group consisting of myrcene, linalool, caryophyllene, borneol, terpineol, sabinene, nerolidol, bisabololand combinations thereof. [00116] According to an aspect of some embodiments of the present invention, there is provided a composition as disclosed herein for use in treating inclusion body myotosis (IBM). According to some such embodiments, the API comprises an aminosalicylate (such as mesalazine). [00117] According to an aspect of some embodiments of the present invention, there is provided a composition as disclosed herein for use in treating Parkinson’s disease. According to some such embodiments, the API comprises an antipsychotic drug (such as levodopa (DOPA), preferably administered together with a DOPA-decarboxylase inhibitor such as carbidopa). [00118] According to an aspect of some embodiments of the present invention, there is provided a composition as disclosed herein for use in treating rheumatoid arthritis. According to some such embodiments, the API comprises a steroid and/or an NSAID. [00119] According to an aspect of some embodiments of the present invention, there is provided a composition as disclosed herein for use in treating type 2 diabetes in a subject in need thereof, wherein said cannabinoid comprises CBD and wherein the API comprises metformuine. According to some such embodiments, the composition further comprises at least one terpene selected from the group consisting of limonene, pinene, linalool, camphene, myrcene, phytol, geraniol, humulene, borneol, eucalyptol and combinations thereof. [00120] According to an aspect of some embodiments of the present invention, there is provided a composition as disclosed herein for use in treating pain in a subject in need thereof, wherein the cannabinoid comprises THC and wherein the API comprises codeine. According to some such embodiments, the composition further comprises at least one terpene selected from the group consisgint of pinene, myrcene, linalool, limonene, sabinene, terpineol, borneol, geraniol, caryophyllene, nerolidol, bisabolol, humulene and combinations thereof. [00121] According to an aspect of some embodiments of the present invention, there is provided a composition as disclosed herein for use in treating a cough in a subject in need thereof, wherein the cannabinoid comprises THC and wherein the API comprises codeine. According to some such embodiments, the composition further comprises at least one terpene selected from the group consisting of pinene, limonene, eucalyptol, caryophyllene, sabinene, geraniol, bisabolol, humulene and combinations thereof. [00122] The present invention further provides pharmaceutical compositions comprising a cannabinoid and a non-cannabinoid compound and uses thereof in the treatment of neurodevelopmental disorders such as autism spectrum disorder (ASD) or neurodegenerative disorders. [00123] The present inventors have surprisingly found that administration of a cannabinoid together with a non-cannabinoid compound selected from the group consisting of an anti- oxidant, an anti-inflammatory agent or a nutraceutical provides improved methods of treatment of neurodevelopmental or neurodegenerative disorders as compared to those obtained using known treatments, such as by increasing the effect obtained, or reducing doses of the cannabinoid and/or of the non-cannabinoid compound required to achieve the same effect as that obtained with use of either the cannabinoid or the non-cannabinoid compound in the absence of the other, which may be particularly important in the case of drugs having significant side-effects or which are addictive. The combined administration may further shorten onset time and/or extend duration of the therapeutic effect due to the different pharmacokinetics of the two drugs. [00124] Compositions comprising both components in a single dosage form have further been found to improve patient compliance. [00125] According to some embodiments, the API is selected from the group consisting of anti-oxidants, anti-inflammatory agents, nutraceuticals and combinations thereof, wherein the non-cannabinoid non-terpene compound has a solubility in medium-chain triglycerides (MCT) of at least 10 mcg/ml at 25 ^oC; and wherein the pharmaceutically acceptable carrier is a non- terpene, non-cannabinoid carrier. [00126] According to an aspect of some embodiments of the present invention, there is provided a pharmaceutical composition comprising at least one cannabinoid; at least one non- cannabinoid, non-terpene compound selected from the group consisting of anti-oxidants, anti- inflammatory agents, nutraceuticals and combinations thereof, wherein said non-cannabinoid compound has a solubility in medium-chain triglycerides (MCT) of at least 10 mcg/ml at 25 ^oC; and a pharmaceutically-acceptable carrier. [00127] According to some embodiments, the composition comprises a dose of between about 1 mg and about 100 mg of the at least one cannabinoid and a dose of between about 1 mg and about 100 mg of the at least one non-cannabinoid compound. According to some embodiments, the dose of the cannabinoid and/or of the non-cannabinoid compound is about 1 mg, about 5 mg, about 10 mg, about 15 mg, about 20 mg, about 25 mg, about 30 mg, about 35 mg, about 40 mg, about 45 mg, about 50 mg, about 55 mg, about 60 mg, about 65 mg, about 70 mg, about 75 mg, about 80 mg, about 85 mg, about 90 mg, about 95 mg or about 100 mg. [00128] According to some embodiments, the carrier is selected from the group consisting of vegetable oils (such as coconut oil, olive oil or sesame oil), pharmaceutical excipients, honey, bees wax, cellulose and combinations thereof. [00129] As used herein, the term “cellulose” refers to cellulose, hemicellulose and combinations thereof. [00130] According to some embodiments, the non-cannabinoid, non-terpene compound is selected from the group consisting of poly-unsaturated fatty acids (PUFA), vitamins, co-enzyme Q10, carotenes and combinations thereof. [00131] According to some embodiments, the PUFA is selected from the group consisting of omega-3 PUFA, omega-6 PUFA and combinations thereof. [00132] According to some embodiments, the vitamin is selected from the group consisting of Vitamin D, Vitamin B12, Vitamin E, Vitamin A, Vitamin K and combinations thereof. [00133] According to some embodiments, the composition further comprises a terpene selected from the group consisting of pinene, limonene, linalool, caryophyllene, caryophyllene oxide, myrcene, humulene, borneol, eucalyptol, terpineol, terpinolene, nerolidol, phytol, geraniol, bisabolol, camphene, beta-amyrin, thujone, citronellol, pulegone, 1,8-cineole, cycloartenol, ocimene, sabinene and combinations thereof. [00134] According to some embodiments, the at least one non-cannabinodi compound comprises one, two, three, four, five or more than five non-cannabinoid compounds. [00135] According to some embodiments, the dose of the non-cannabinoid compound is at least 10% (such as 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 99%) smaller than the dose required to achieve the same effect in the absence of the cannabinoid. [00136] According to some embodiments, the dose of the cannabinoid is at least 10% (such as 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 99%) smaller than the dose required to achieve the same effect in the absence of the non-cannabinoid compound. [00137] According to some embodiments, the non-cannabinoid compound modulates the effect of the cannabinoid. According to some such embodiments, the non-cannabinoid compound modulates the interaction between the cannabinoid and a receptor of the endocannabinoid system. [00138] According to some embodiments, the cannabinoid modulates the effect of the non- cannabinoid compound. [00139] According to some embodiments, the composition comprises CBD and at least two non-cannabinoid non-terpene compounds. [00140] According to some embodiments, the composition is liquid at 25^oC. [00141] According to some embodiments, the cannabinoid is adsorbed on a porous carrier. [00142] According to some embodiments, the composition of the present invention is for use in treating a neurodevelopmental disorder (such as autism spectrum disorder (ASD), attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD). [00143] According to some embodiments, there is provided a composition comprising at least one cannabinoid for co-administration with at least one non-cannabinoid compound selected from the group consisting of vitamins, anti-oxidants, anti-inflammatory agents, nutraceuticals and combinations thereof, wherein said non-cannabinoid compound has a solubility in medium-chain triglycerides (MCT) of at least 10 mcg/ml at 25 ^oC, for use in the treatment of a neurodevelopmental disorder or a neurodegenerative disorder. [00144] According to some embodiments, the neurodevelopmental disorder is selected from the group consisting of autism spectrum disorder (ASD), attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), learning disability, intellectual disability, cerebral palsy, seizures, conduct disorder, communication disorder, neurodevelopmental motor disorder, Alzheimer's disease, dementia, multiple sclerosis, Parkinson's disease, Huntington's disease, motor neuron disease and amyotrophic lateral sclerosis. [00145] According to some embodiments, the composition is for use in treating a neurodevelopmental disorder or a neurodegenerative disorder. [00146] According to some embodiments, the composition comprises from about 17.5 to about 525 mg CBD, such as about 17.5, about 20, about 50, about 100, about 150, about 200, about 250, about 300, about 350, about 400, about 450, about 500 or about 525 mg CBD. [00147] According to some embodiments, the composition comprises from about 17.5 mcg to about 1,500 mcg Vitamin B12, such as about 17.5, about 20, about 50, about 100, about 200, about 300, about 400, about 500, about 600, about 700, about 800, about 900, about 1,000, about 1,100, about 1,200, about 1,300, about 1,400 or about 1,500 mcg Vitamin B12. [00148] According to some embodiments, the composition comprises from about 1 mcg to about 500 mcg Vitamin D, such as about 1 mcg, about 10 mcg, about 50 mcg, about 100 mcg, about 200 mcg, about 300 mcg, about 400 mcg, about 500 mcg, about 600 mcg, about 700 mcg, about 800 mcg, about 900 mcg, about 1 mg, about 10 mg, about 50 mg, about 100 mg, abaout 200 mg, about 300 mg, about 400 mg or about 500 mg. [00149] According to some embodiments, the composition comprises from about 0.5 to about 1.5 g Omega-3 PUFA, such as about 0.5, about 0.6, about 0.7, about 0.8, about 0.9, about 1.0, about 1.1, about 1.2, about 1.3, about 1.4 or about 1.5 g. [00150] According to some embodiments, the composition is for administration once, twice, three times, four times, five times or six times per day. [00151] According to some embodiments, there is provided a product comprising the composition as disclosed herein, selected from the group consisting of oils, tablets, gel capsules, medical patches, cigarettes, vaporizer liquids, suppositories, tampons and rectal candles. [00152] According to some embodiments, there is provided a method for treating a neurodevelopment disorder or a neurodegenerative disorder in a subject in need thereof, the method comprising administering to the subject a dose of a composition as disclosed herein. [00153] According to some embodiments, the dose comprises from about 0.5 to about 30 mg CBD per 1Kg of body weight per day. [00154] According to some embodiments, the dose comprises 1 to 3000 mcg Vitamin B12. [00155] According to some embodiments, the dose comprises 0.5 to 1000 mcg Vitamin D. [00156] According to some embodiments, the dose comprises 0.1 to 3 gr Omega-3 PUFA. [00157] According to an aspect of some embodiments of the present invention, there is provided a method for treating a neurodevelopmental disorder or a neurodegenerative disorder in a subject in need thereof, the method comprising administering to the subject at least one cannabinoid and at least one non-cannabinoid, non-terpene compound selected from the group consisting of anti-oxidants, anti-inflammatory agents nutraceuticals and combinations thereof, wherein said non-cannabinoid non-terpene compound has a solubility in medium-chain triglycerides (MCT) of at least 10 mcg/ml at 25^ºC. [00158] According to some embodiments, the at least one cannabinoid and the at least one non-cannabinoid non-terpene compound are administered in separate dosage forms. [00159] According to an embodiment of any aspect of the present invention, the composition comprises the at least one cannabinoid and the API in a single dosage form. According to some embodiments, the composition is provided in a dosage form suitable for oral administration, such as, for example, as a pill, tablet, capsule, syrup, solution, suspension, powder or the like, or a combination thereof. [00160] According to some embodiments, the composition is provided in a dosage from suitable for sublingual administration, such as a sublingual oil. [00161] According to an embodiment, the composition is provided in a form suitable for administration by inhalation, such as, for example, in an aerosol, inhaler, nebulizer, vaporizer or the like, or combinations thereof. [00162] According to an embodiment, the composition is provided in a form suitable for parenteral administration, such as for example, for administration by intradermal, subcutaneous, intramuscular, intraosseous, intraperitoneal or intravenous injection, or any combination thereof. [00163] According to an embodiment, the composition is provided in a form suitable for buccal administration, such as an oil. [00164] According to an embodiment, the composition comprises a suppository, such as a vaginal suppository (including a douche, pessary or the like), a rectal suppository, urethral suppository or nasal suppository, or any combination thereof. [00165] According to an embodiment, the composition is provided in a cigarette. [00166] According to an embodiment, the composition is provided in a form suitable for topical administration, such as, for example, in a cream, ointment, gel, oil, patch or combinations thereof. [00167] According to some embodiments, the at least one cannabinoid and the at least one non-cannabinoid compound are administered in separate dosage forms, wherein administration of the dosage forms is carried out independently, sequentially, simultaneously or concomitantly. [00168] According to an aspect of some embodiments of the present invention, there is provided a product comprising the composition as disclosed herein, wherein the product is selected from the group consisting of sublingual oils, tablets, gel capsules, medical patches, suppositories, cigarettes, vaporizer liquids, tampons and rectal candles. [00169] According to an aspect of some embodiments of the present invention, there is provided a method for treating a neurodevelopment disorder or a neurodegenerative disorder in a subject in need thereof, the method comprising administering to the subject a dose of a composition as disclosed herein. [00170] According to some embodiments, the dose comprises from about 0.5 to about 30 mg (such as about 0.5, about 1, about 5, about 10, about 15, about 20, about 25 or about 30) CBD per 1Kg of body weight per day. [00171] According to some embodiments, the dose comprises from about 1 to about 3000 mcg (such as about 1, about 100, about 500, about 1000, about 1500, about 2000, about 2500 or about 3000) mcg Vitamin B12. [00172] According to some embodiments, the dose comprises from about 0.5 to about 1000 (such as above 0.5, about 1, about 5, about 10, about 50, about 100, about 200, about 300, about 400, about 500, about 600, about 700, about 800, about 900 or about 1000) mcg Vitamin D. [00173] According to some embodiments, the dose comprises from about 0.1 to about 3 (such as about 0.1, about 0.5, about 1.0, about 1.5, about 2.0, about 2.5 or about 3.0) gr Omega- 3 PUFA. [00174] According to some embodiments, there is provided a method for treating a neurodevelopmental disorder or a neurodegenerative disorder in a subject in need thereof, the method comprising administering to the subject at least one cannabinoid and at least one non- cannabinoid compound selected from the group consisting of anti-oxidants, anti-inflammatory agents, nutraceuticals and combinations thereof, wherein said non-cannabinoid compound has a solubility in medium-chain triglycerides (MCT) of at least 10 mcg/ml at 25^ºC. [00175] According to some embodiments, the at least one cannabinoid and the at least one non-cannabinoid compound are administered in a single dosage form. [00176] According to some embodiments, the at least one cannabinoid and the at least one non-cannabinoid compound are administered in separate dosage forms, wherein administration of the dosage forms is carried out independently, sequentially, simultaneously or concomitantly. [00177] According to a further aspect of some embodiments of the present invention, there is provided a method for treating acute pain in a subject in need thereof, the method comprising administering to the subject a composition as disclosed herein, wherein said at least one cannabinoid comprises between 11 and 40 mg tetrahydrocannabinol (THC) and between 11 and 40 mg cannabidiol (CBD) administered within a 24 period measured from commencement of treatment and said API comprises a non-cannabis non-terpene analgesic at a dose no greater than 90% of a dose of said analgesic required to provide a same effect in the subject in the absence of THC and CBD. [00178] According to some embodiments, about 11 mg, about 12 mg, about 15 mg, about 20 mg, about 25 mg, about 30 mg, about 35 mg or about 40 mg of THC is administered within the 24-hour period. [00179] According to some embodiments, about 11 mg, about 12 mg, about 15 mg, about 20 mg, about 25 mg, about 30 mg, about 35 mg or about 40 mg of CBD is administered within the 24-hour period. [00180] According to some embodiments, the dose of the non-cannabis analgesic administered is about 90%, about 85%, about 80%, about 75%, about 70%, about 65%, about 60%, about 55%, about 50%, about 45%, about 40%, about 35%, about 30%, about 25%, about 20%, about 15%, about 10%, about 5%, about 1%, about 0.5%, about 0.1% or less than about 0.1% of the dose of a non-cannabis analgesic required to provide the same effect in the subject in the absence of THC and CBD. [00181] According to some embodiments, the method is substantially devoid of administering of a non-cannabis analgesic i.e. no greater than about 10mg (such as about 10 mg, about 9 mg, about 8 mg, about 7 mg, about 6 mg, about 5 mg, about 4 mg, about 3 mg, about 2 mg, about 1 mg, or about 0 mg) of a non-cannabis analgesic is administered to the subject within the 24-hour period. [00182] According to some embodiments, the method further comprises administering at least one terpene (such as one terpene, two terpenes, three terpenes, four terpenes, five terpenes or six terpenes) selected from the group consisting of pinene, myrcene, sabinene, limonene, linalool, terpineol, eucalyptol, borneol, caryophyllene, humulene, nerolidol, bisabolol and combinations thereof. According to some such embodiments, a total terpene to total cannabinoid weight/weight ratio is in the range between 0.05:1 and 1:1. [00183] According to some embodiments, the method further comprises administering between 1 and 150 mg of the non-cannabis analgesic. According to some such embodiments, administering of the non-cannabis analgesic is carried out within the 24-hour period. [00184] According to some embodiments, the non-cannabis analgesic, the THC and/or the CBD are administered in a single composition. [00185] According to some embodiment, the non-cannabis analgesic is administered in a separate dosage form from the THC and/or the CBD. According to some embodiments, the THC and the CBD are administered together in a first composition and the non-cannabis analgesic is administered in a second composition. According to some embodiments, the THC and the non-cannabis analgesic are administered together in a first composition and the CBD is administered in a second composition. According to some embodiments, the CBD and the non- cannabis analgesic are administered together in a first composition and the THC is administered in a second composition. According to some embodiments, each of the THC, the CBD and the non-cannabis analgesic are administered in a separate dosage form. According to some embodiments, the THC and/or the CBD and the non-cannabis analgesic are administered sequentially, simultaneously or concomitantly. [00186] According to some embodiments, the non-cannabis analgesic is an opioid. According to some such embodiments, the opioid is morphine. [00187] According to some embodiments, the method comprises administering between 1 and 150 mg of morphine. [00188] According to some embodiments, administering of the analgesic is carried out within the 24-hour period. [00189] According to some embodiments, the acute pain is selected from the group consisting of acute neuropathic pain, acute radicular pain, acute post-operative pain, acute traumatic pain, acute inflammatory-derived pain and combinations thereof. [00190] According to some embodiments, the acute pain is acute neuropathic pain. [00191] According to some embodiments, the acute pain is acute radicular pain. [00192] According to some embodiments, the method further comprises administering at least a second dose of THC and/or CBD during the 24-hour period. [00193] According to some embodiments, the composition is administered once. [00194] According to some embodiments, the subject is a male, particularly a human male. [00195] According to a further aspect of some embodiments of the present invention, there is provided a composition comprising THC for coadministration with CBD for use in treating acute pain, wherein THC is for administration to the subject at between 11 and 40 mg and CBD is for administration to the subject at between 11 and 40 mg CBD within a 24 period measured from commencement of treatment and no greater than about 90% of the dose of a non-cannabis non-terpene analgesic required to provide the same effect in the subject in the absence of THC and CBD. [00196] According to some embodiments, the composition is for administration substantially in the absence of administration of a non-cannabis non-terpene analgesic to the subject within the 24-hour period. [00197] According to some embodiments, the composition is further for co-administration with at least one terpene (such as one terpene, two terpenes, three terpenes, four terpenes, five terpenes or six terpenes) selected from the group consisting of pinene, myrcene, sabinene, limonene, linalool, terpineol, eucalyptol, borneol, caryophyllene, humulene, nerolidol, bisabolol and combinations thereof. According to some such embodiments, a total terpene to total cannabinoid weight/weight ratio is in the range between 0.05:1 and 1:1. [00198] According to some embodiments, the composition is further for co-administration with between 1 and 150 mg of the non-cannabis. According to some such embodiments, the composition is for co-administration with the non-cannabis analgesic within the 24-hour period. [00199] According to some embodiments, the composition is further for co-administration with between 1 and 150 mg of the non-cannabis. According to some such embodiments, the composition is for co-administration with the non-cannabis analgesic within the 24-hour period. [00200] According to some embodiments, the non-cannabis analgesic is for administration in a separate dosage form from the THC and/or the CBD. According to some embodiments, the THC and the CBD are for administration together in a first composition and the non- cannabis analgesic is for administration in a second composition. According to some embodiments, the THC and the non-cannabis analgesic are for administration together in a first composition and the CBD is for administration in a second composition. According to some embodiments, the CBD and the non-cannabis analgesic are for administration together in a first composition and the THC is for administration in a second composition. According to some embodiments, each of the THC, the CBD and the non-cannabis analgesic are for administration in a separate dosage form. According to some embodiments, the THC and/or the CBD and the non-cannabis analgesic are for administration sequentially, simultaneously or concomitantly. [00201] According to some embodiments, the analgesic, the THC and/or the CBD are for co- administration in a single composition. [00202] According to some embodiments, the analgesic is an opioid. According to some such embodiments, the opioid is morphine. [00203] According to some embodiments, the acute pain is selected from the group consisting of acute neuropathic pain, acute radicular pain, acute post-operative pain, acute traumatic pain, acute inflammatory-derived pain and combinations thereof. According to some embodiments, the acute pain is acute neuropathic pain. According to some embodiments, the acute pain is acute radicular pain. [00204] According to some embodiments, the composition is for further co-administration with at least one additional dose of CBD within the 24-hour period. [00205] According to some embodiments, the composition is for a single administration. [00206] According to some embodiments, the composition is for administration to a male subject, particularly a male human subject. According to an embodiment of any of the compositions disclosed herein, the composition further comprises at least one herbal preparation. Example [00207] Subject group [00208] Otherwise healthy patients ( ASA-class 1 or 2, age 18-70) presenting with complaints of severe lumbar and radicular pain of 6 or more on the Visual Analogue Scale (VAS 6) in their lower extremity. All patients were diagnosed with acute lumbar radicular pain based on clinical presentation, physical exams, and Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) findings consistent with the diagnosis. Patients were excluded from the study if they had undergone past spine surgery, suffered from chronic radicular symptoms, had used cannabis or opioid in the past month, had a history of psychiatric disease or ischemic heart disease, or were pregnant or lactating. [00209] Patients were randomly divided into one of three groups, each treated by a different study drug as follows; (1) Cannabis extract of high dose (comprising 20mg THC and 20mg CBD), (2) cannabis extract of low dose (comprising 10mg THC and 10mg CBD), and (3) placebo – an extract of similar appearance comprising no cannabinoids. [00210] Patients were enrolled to study at the emergency room. After signing the consent form, patients were hospitalized and admitted to the orthopedic department. In the ward, patients received a single dose comprising 3 drops of the study drug via sublingual administration. Patients were connected to a PCA (patient-controlled administration) morphine pump allowing self-administration of opioid for pain. While patients could push the PCA pump with no limit, the actual amount of morphine administered via the pump was 1 mg per 10 minutes at maximum. Patients were followed up for 24 hours repeatedly evaluating opioid consumption (total number of effective pushes on the PCA pump). [00211] Results are presented in FIG.1. [00212] As seen in the figure, a statistically significant reduction in total effective pushes, indicating a reduction in the morphine requirement, was shown over a 24-hour period in the patient group which received cannabis extract of high dose, as compared to the patient groups which received cannabis extract of low dose or placebo. [00213] The scope of the invention shall include all modifications and variations that may fall within the scope of the attached claims. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

Claims

CLAIMS 1. A composition comprising at least one cannabinoid, at least one non-cannabinoid, non- terpene compound and a pharmaceutically-acceptable carrier.

2. The composition of claim 1, wherein said at least one cannabinoid is selected from the group consisting of tetrahydrocannabiniol in acid or decarboxylated form (THCa or THC, respectively), cannabidiol in acid or decarboxylated form (CBDa or CBD, respectively), cannabigerol in acid or decarboxylated form (CBGa or CBG, respectively), cannabichromene in acid or decarboxylated form (CBCa or CBC, respectively) tetrahydrocannabivarin in acid or decarboxylated form (THCVa or THCV, respectively), Cannabidivarin in acid or decarboxylated form (CBDVa or CBDV respectively) and cannabinol in acid or decarboxylated form (CBNa or CBN, respectively) and combinations thereof, and combinations thereof.

3. The composition of claim 1, further comprising at least one terpene selected from the group consisting of bisabolol, borneol, camphor, carene, caryophyllene, eucalyptol, geraniol, humulene, myrcene, limonene, linalool, nerolidol, ocimene, pinene, sabine, terpineol and combinations thereof.

4. The composition of claim 1, wherein the non-cannabinoid, non-terpene compound is an active pharmaceutical ingredient (API).

5. The composition of claim 4, wherein a dose of said API is at least 10% smaller than a dose required to achieve the same effect in the absence of said cannabinoid.

6. The composition of claim 4, wherein a dose of said cannabinoid is at least 10% smaller than a dose required to achieve the same effect in the absence of said API.

7. The composition of claim 4, wherein said at least one API is selected from the group consisting of an analgesic drug, an anti-inflammatory drug, a drug affecting serotonin levels in serum or plasma, a central nervous system (CNS) stimulant, a drug for treating a sleep disorder, a dopamine agonist or precursor thereof, an antidepressant, an antipsychotic drug, an anti- spasmodic drug, a bisphosphonate, a dopamine antagonist, a central adrenergic inhibitor, an aminosalicylate, an anti-oxidant, an ergot alkaloid, an anesthetic and combinations thereof.

8. The composition of claim 7, wherein said API comprises an analgesic drug and said cannabinoid comprises THC.

9. The composition of claim 8, wherein said analgesic drug is selected from the group consisting of a natural or synthetic opioid, a centrally acting non-opioid analgesic, a gabapentinoid, an anti-inflammatory drug and combinations thereof.

10. The composition of claim 9, wherein said natural opioid is selected from the group consisting of opium, morphine, codeine, heroin and combinations thereof.

11. The composition of claim 9, wherein said synthetic opioid is selected from the group consisting of tramadol hydrochloride, dextromethorphan, dextropropoxyphene, loperamide, hydocodone, oxycodone, oxymorphone, meperidine, methadone, fentanyl, carfenatyl and combinations thereof.

12. The composition of claim 9, wherein said centrally acting non-opioid analgesic is selected from the group consisting of paracetamol, nefopam, flupirtine, dipyrone and combinations thereof.

13. The composition of claim 9, wherein said gabapentinoid is selected from the group consisting of pregabalin, gabapentin, microgabalin, phenibut and combinations thereof.

14. The composition of claim 7, wherein said anti-inflammatory drug is selected from the group consisting of a steroid, a non-steroidal anti-inflammatory drug (NSAID), a biological anti-inflammatory drug and combinations thereof.

15. The composition of claim 14, wherein said NSAID is selected from the group consisting of ibuprofen, dipyrone, aspirin, naproxen, diclofenac, acelofenac, celecoxib, mefenamic acid, etoricoxib, etodolac, indomethacin and combinations thereof.

16. The composition of claim 7, wherein said API comprises an anti-inflammatory drug and said cannabinoid comprises CBD.

17. The composition of claim 14, wherein said steroid is selected from the group consisting of hydrocortisone, cortisone, prednisone, prednisolone, methylprednisolone, dexamethasone, betamethasone, triamcinolone, deflazacort, fludrocortisone acetate, deoxycorticosterone acetate, aldosterone, beclomethasone, fluticasome, budesonide and combinations thereof.

18. The composition of claim 14, wherein said biological anti-inflammatory drug is selected from the group consisting of a Tumor Necrosis Factor (TNF)-α inhibitor, a B-cell inhibitor, an interleukin inhibitor, a Selective Co-Stimuloation Modulator and combinations thereof.

19. The composition of claim 7, wherein said API comprises a drug affecting serotonin levels and said cannabinoid comprises CBD.

20. The composition of claim 19, wherein said drug affecting serotonin levels is selected from the group consisting of a Selective Serotonin Reuptake Inhibitor (SSRI) and a Serotonin and Norepinephrine Reuptake Inhibitor (SNRI) such as duloxetine.

21. The composition of claim 20, wherein said SSRI is selected from the group consisting of citalopram, dapoxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vortioxetine, triptan and combinations thereof.

22. The composition of claim 20, wherein said SNRI is selected from the group consisting of duloxetine, desvenlafaxine, venlafaxine, milnacipran, levomilnacipran and combinations thereof.

23. The composition of claim 7, wherein said API comprises a central nervous CNS stimulant and said cannabinoid is selected from the group consisting of CBD, THC and a combination thereof.

24. The composition of claim 23, wherein said CNS stimulant is selected from the group consisting of methylphenidate hydrochloride, an amphetamine, armodafinil, atomoxetine, cocaine, modafinil, oxybate, pitolisant, solriamfetol, caffeine and combinations thereof.

25. The composition of claim 7, wherein said API comprises a drug for treating a sleep disorder and said cannabinoid is selected from the group consisting of THC, CBD and a combination thereof

26. The composition of claim 25, wherein said drug for treating a sleep disorder is selected from the group consisting of a benzodiazepine, a non-benzodiazepine hypnotic, a melatonin receptor agonist, an antispasmodic drug, an antinarcoleptic drug, an antidepressant, an orexin receptor antagonist and combinations thereof.

27. The composition of claim 26, wherein said benzodiazepine is selected from the group consisting of alprazolam, clonazepam, diazepam, estazolam, orazepam, temazepm and combinations thereof.

28. The composition of claim 26, wherein said non-benzodiazepine hypnotic is selected from the group consisting of eszopiclone, zaleplon, zolpidem, zopiclone, zopiclone, diphenhydramine, ramelteron, or a herbal sedative such as Valeriana officinalis and combinations thereof.

29. The composition of claim 26, wherein said melatonin receptor agonist comprises melatonin and/or ramelteon.

30. The composition of claim 26, wherein said antispasmodic is selected from the group consisting of carbamazepine, gabapentin enacarbil, pregabalin, valproate and combinations thereof.

31. The composition of claim 26, wherein said antinarcoleptic is selected from the group consisting of methylphenidate, modafinil, pitolisant, sodium oxybate and combinations thereof.

32. The composition of claim 26, wherein said antidepressant is selected from the group consisting of mirtazapine, quetiapine and combinations thereof.

33. The composition of claim 26, wherein said orexin receptor antagonist is selected from the group consisting of daridorexant, lemborexant, suvorexant and combinations thereof.

34. The composition of claim 7, wherein said dopamine agonist is selected from the group consisting of gabapentin enacarbil, pramipexole, ropinirole, rotigotine and combinations thereof.

35. The composition of claim 34, wherein said cannabinoid is selected from the group consisting of CBD, THC and a combination thereof.

36. The composition of claim 7, wherein said antidepressant comprises a monoamine oxidase inhibitor.

37. The composition of claim 36, wherein said monoamine oxidase inhibitor is selected from the group consisting of isocarboxazid, phenelzine, selegiline, tranylcypromine, moclobemide and combinations thereof.

38. The composition of claim 7, wherein said antipsychotic drug is selected from the group consisting of a typical antipsychotic, an atypical antipsychotic and a combination thereof.

39. The composition of claim 38, wherein said typical antipsychotic comprises an SRNI or a tricyclic antidepressant.

40. The composition of claim 39, wherein said typical antipsychotic is selected from the group consisting of chlorpromazine, droperidol, flupenthixol, fluphenazine, haloperidol, loxapine, perphenazine, pimozide, trifluoperazine, thiothixene, zuclopenthixol and combinations thereof.

41. The composition of claim 39, wherein said atypical antipsychotic is selected from the group consisting of risperidone, quetiapine, olanzapine, ziprasidone, paliperidone, aripiprazole, clozapine and combinations thereof.

42. The composition of Claim 41, wherein said cannabinoid comprises CBD.

43. The composition of claim 7, wherein said anti-spasmodic drug is selected from the group consisting of a smooth muscle relaxant and an anticholinergic agent.

44. The composition of claim 43, wherein said smooth muscle relaxant is selected from the group consisting of alverine, mebeverine, peppermint oil and anticholinergic combinations thereof.

45. The composition of claim 44, wherein said anticholinergic agent is selected from the group consisting of dicycloverine, cyclobenzaprine, hyoscine, atropine, propantheline and combinations thereof.

46. The composition of claim 45, wherein said cannabinoid comprises THC.

47. The composition of claim 7, wherein said bisphosphonate is selected from the group consisting of alendronate, risedronate, ibandronate, pamidronate, zoledronic acid and combinations thereof.

48. The composition of claim 7, wherein said anesthetic drug is selected from the group consisting of lidocaine, prilocaine, bupivacaine, propofol, etomidate and ketamine.

49. The composition of claim 1, wherein said at least one non-cannabinoid, non-terpene compound is selected from the group consisting of anti-oxidants, anti-inflammatory agents, nutraceuticals and combinations thereof, wherein said non-cannabinoid non-terpene compound has a solubility in medium-chain triglycerides (MCT) of at least 10 mcg/ml at 25 ^oC; and wherein said pharmaceutically acceptable carrier is a non-terpene, non-cannabinoid carrier.

50. The composition of claim 1, wherein said carrier is selected from the group consisting of vegetable oils, pharmaceutical excipients, honey, bees wax, cellulose and combinations thereof.

51. The composition of claim 49, wherein said non-cannabinoid, non-terpene compound is selected from the group consisting of poly-unsaturated fatty acids (PUFA), vitamins, co- enzyme Q10, carotenes and combinations thereof.

52. The composition of claim 50, wherein said PUFA is selected from the group consisting of omega-3 PUFA, omega-6 PUFA and combinations thereof.

53. The composition of claim 50, wherein said vitamin is selected from the group consisting of Vitamin D, Vitamin B12, Vitamin E, Vitamin A, Vitamin K and combinations thereof.

54. The composition of claim 49, further comprising a terpene selected from the group consisting of pinene, limonene, linalool, caryophyllene, caryophyllene oxide, myrcene, humulene, borneol, eucalyptol, terpineol, terpinolene, nerolidol, phytol, geraniol, bisabolol, camphene, beta-amyrin, thujone, citronellol, pulegone, 1,8-cineole, cycloartenol, ocimene, sabinene and combinations thereof.

55. The composition of claim 1, comprising CBD and at least two non-cannabinoid non- terpene compounds.

56. The composition of claim 1, wherein said cannabinoid is adsorbed on a porous carrier.

57. The composition of claim 1, wherein said composition is liquid at 25^oC.

58. The composition of claim 49, for use in treating a neurodevelopmental disorder or a neurodegenerative disorder.

59. The composition for use of claim 58, comprising from about 17.5 to about 525 mg CBD.

60. The composition for use of claim 58, comprising from about 1 mcg to about 1,500 mcg Vitamin B12.

61. The composition for use of claim 58, comprising from about 1 to about 500 mcg Vitamin D.

62. The composition for use of claim 58, comprising from about 0.5 to about 1.5 g Omega- 3 PUFA.

63. A product comprising the composition of claim 1, selected from the group consisting of oils, tablets, gel capsules, medical patches, cigarettes, vaporizer liquids, suppositories, tampons and rectal candles.

64. A method for treating a neurodevelopment disorder or a neurodegenerative disorder in a subject in need thereof, the method comprising administering to the subject a dose of a composition according to claim 49.

65. The method of claim 64, wherein said dose comprises from about 0.5 to about 30 mg CBD per 1Kg of body weight per day.

66. The method of claim 64, wherein said dose comprises 1 to 3000 mcg Vitamin B12.

67. The method of claim 64, wherein said dose comprises 0.5 to 1000 mcg Vitamin D.

68. The method of claim 64, wherein said dose comprises 0.1 to 3 gr Omega-3 PUFA.

69. A method for treating a neurodevelopmental disorder or a neurodegenerative disorder in a subject in need thereof, the method comprising administering to the subject at least one cannabinoid and at least one non-cannabinoid, non-terpene compound selected from the group consisting of anti-oxidants, anti-inflammatory agents, nutraceuticals and combinations thereof, wherein said non-cannabinoid non-terpene compound has a solubility in medium-chain triglycerides (MCT) of at least 10 mcg/ml at 25^ºC.

70. The method of claim 69, wherein said at least one cannabinoid and said at least one non-cannabinoid non-terpene compound are administered in separate dosage forms.

71. A composition according to claim 4, for use in treating agitation or anxiety in a subject in need thereof, wherein said cannabinoid is selected from the group consisting of CBD, CBG, CBC and combinations thereof, and said API comprises an antipsychotic agent and/or a benzodiazepin.

72. The composition of claim 71, further comprising at least one terpene selected from the group consisting of pinene, myrcene, limonene, linalool, eucalyptol, terpineol, borneol, caryophyllene, nerolidol, bisabolol and combinations thereof.

73. The composition of claim 71, wherein said subject has been diagnosed with dementia or with autism spectrum disorder (ASD).

74. A composition according to claim 4, for use in treating Tourette syndrome in a subject in need thereof, wherein said cannabinoid is selected from the group consisting of THC, CBD and a combination thereof, wherein said API is selected from the group consisting of a dopamine antagonist, an atypical antipsychotic, a central adrenergic inhibitor, an antidepressant, a benzamide and combinations thereof.

75. The composition of claim 74, further comprising at least one terpene selected from the group consisting of pinene, myrcene, limonene, linalool, eucalyptol, terpineol, borneol, caryophyllene, nerolidol and combinations thereof.

76. A composition according to claim 4, for use in treating endometriosis in a subject in need thereof, wherein said cannabinoid is selected from the group consisting of THC, CBD and a combination thereof, and wherein said API is selected from the group consisting of a hormone, an analgesic and a combination thereof.

77. The composition of claim 76, further comprising at least one terpene selected from the group consisting of pinene, myrcene, linalool, limonene, sabinene, terpineol, borneol, geraniol, caryophyllene, nerolidol, bisabolol, humulene and combinations thereof.

78. A composition according to claim 4, for use in treating fibromyalgia in a subject in need thereof, wherein said cannabinoid is selected from the group consisting of THC, CBD and a combination thereof, and wherein said API is selected from the group consisting of an analgesic, an antidepressant, an anticonvulsant and combinations thereof.

79. The composition of claim 78, further comprising at least one terpene selected from the group consisting of pinene, myrcene, linalool, limonene, sabinene, terpineol, borneol, geraniol, caryophyllene, nerolidol, bisabolol, humulene and combinations thereof.

80. A composition according to claim 4, for use in treating osteoarthritis in a subject in need thereof, wherein said cannabinoid is selected from the group consisting of THC, CBD, CBG, CBC and combinations thereof, and wherein said API comprises an anti-inflammatory analgesic.

81. The composition of claim 80, further comprising at least one terpene selected from the group consisting of pinene, myrcene, linalool, sabinene, terpineol, borneol, geraniol, caryophyllene, nerolidol, humulene, limonene and combinations thereof and combinations thereof and combinations thereof.

82. A composition according to claim 4, for use in treating Amyotrophic Lateral Sclerosis (ALS) in a subject in need thereof, wherein said cannabinoid is selected from the group consisting of THC, CBG and a combination thereof, and wherein said API comprises riluzole.

83. The composition of claim 82, further comprising at least one terpene selected from the group consisting of linalool, limonene, eucalyptol, myrcene, caryophyllene, linalool, borneol, sabinene, terpineol, pinene, ocimene, bisabolol and combinations thereof.

84. A composition according to claim 4, for use in treating a symptom of multiple sclerosis (MS) in a subject in need thereof, wherein said cannabinoid is selected from the group consisting of THC, CBD, CBG and combinations thereof, and wherein said API comprises an anti-inflammatory agent.

85. The composition of claim 84, further comprising at least one terpene selected from the group consisting of pinene, myrcene, caryophyllene, limonene, eucalyptol, linalool, humulene, borneol, sabinene, terpineol, geraniol, nerolidol, bisabolol and combinations thereof.

86. A composition according to claim 4, for use in treating Huntington’s disease in a subject in need thereof, wherein said cannabinoid is selected from the group consisting of THC, CBD, CBG and combinations thereof, and wherein said API is selected from the group consisting of an antipsychotic drug, an antidepressant and an antidyskinetic drug.

87. The composition of Claim 86, further comprising at least one terpene selected from the group consisting of linalool, limonene, pinene, myrcene, humulene, borneol, sabinene, terpineol, caryophyllene, humulene and combinations thereof.

88. A composition according to claim 4, for use in treating osteoporosis in a subject in need thereof, wherein said cannabinoid comprises CBD and said API is selected from the group consisting of a bisphosphonate, an analgesic and a combination thereof.

89. The composition of claim 88, further comprising at least one terpene selected from the group consisting of caryophyllene, humulene, carene, camphor, pinene, borneol, limonene, nerolidol and combinations thereof.

90. A composition according to claim 4, for use in treating cystic fibrosis in a subject in need thereof, wherein said cannabinoid is selected from the group consisting of CBD, THC and a combination thereof, and wherein said API is selected from the group consisting of an antibiotic, a mucolytic, a bronchodilator, an anti-inflammatory drug and combinations thereof.

91. The composition of claim 90, further comprising at least one terpene selected from the group consisting of pinene, limonene, eucalyptol, caryophyllene, sabinene, geraniol, bisabolol, humulene and combinations thereof.

92. A composition according to claim 4, for use in treating migraine a subject in need thereof, wherein said cannabinoid is selected from the group consisting of THC, CBC and a combination thereof, and said API is selected from the group consisting of an analgesic, an SSRI, an ergot alkaloid, an anesthetic and combinations thereof.

93. The composition of claim 92, further comprising at least one terpene selected from the group consisting of caryophyllene, ocimene, terpineol, linalool, limonene, myrcene, borneol, sabinene, pinene, nerolidol, bisabolol and combinations thereof.

94. A composition according to claim 4, for use in treating phantom pains in a subject in need thereof, wherein said cannabinoid comprises THC and wherein said API is selected from the group consisting of an NSAID, an antidepressant, an antispasmodic, a beta blocker, a muscle relaxant and combinations thereof.

95. The composition of claim 94, further comprising at least one terpene selected from the group consisting of myrcene, linalool, caryophyllene, borneol, terpineol, sabinene, nerolidol, bisabolol and combinations thereof.

96. A composition according to claim 4, for use in treating inclusion body myotosis (IBM) in a subject in need thereof, wherein said API comprises an aminosalicylate, optionally mesalazine.

97. A composition according to claim 4, for use in treating Parkinson’s disease in a subject in need thereof, wherein said API comprises levodopa and optionally carbidopa.

98. A composition according to claim 4, for use in treating rheumatoid arthritis in a subject in need thereof, wherein said API is selected from the group consisting of a steroid, an NSAID and a combination thereof.

99. A composition according to claim 4, for use in treating type 2 diabetes in a subject in need thereof, wherein said cannabinoid comprises CBD and wherein said API comprises metformuine.

100. The composition of claim 99, further comprising at least one terpene selected from the group consisting of limonene, pinene, linalool, camphene, myrcene, phytol, geraniol, humulene, borneol, eucalyptol and combinations thereof.

101. A composition according to claim 4, for use in treating pain in a subject in need thereof.

102. The composition of for use of claim 101, wherein said cannabinoid comprises THC and wherein said API comprises codeine.

103. The composition of claim 101, further comprising at least one terpene selected from the group consisgint of pinene, myrcene, linalool, limonene, sabinene, terpineol, borneol, geraniol, caryophyllene, nerolidol, bisabolol, humulene and combinations thereof.

104. The composition of claim 4, wherein said cannabinoid comprises THC and/or CBD in an amount of between 5 and 40 mg and wherein said API is a non-cannabis non-terpene analgesic in an amount that is no greater than 90% of a dose of said analgesic required to provide a same effect in the subject in an absence of said THC and CBD.

105. A composition according to claim 4, for use in treating a cough in a subject in need thereof, wherein said cannabinoid comprises THC and wherein said non-cannabinoid API comprises codeine.

106. The composition of claim 104, further comprising at least one terpene selected from the group consisting of pinene, limonene, eucalyptol, caryophyllene, sabinene, geraniol, bisabolol, humulene and ^{combinations thereof.}

107. The composition of claim 1, for administration in a dosage form selected from the group consisting of a pill, a tablet, a capsule, a syrup, a solution, a suspension, a powder, an aerosol, an inhaler, a nebulizer, a vaporizer, an injection solution, a vaginal suppository, a rectal suppository, an urethral suppository, a nasal suppository, a cigarette, a cream, an ointment, a gel, an oil, a sublingual oil, a patch or a combination thereof.

108. The composition of claim 1, further comprising at least one herbal extract.

109. A method for treating agitation or anxiety in a subject in need thereof, comprising administering to the subject a composition according to claim 4, wherein said cannabinoid is selected from the group consisting of CBD, CBG, CBC and combinations thereof, and said API comprises an antipsychotic agent and/or a benzodiazepin.

110. The method of claim 109, further comprising administering at least one terpene selected from the group consisting of pinene, myrcene, limonene, linalool, eucalyptol, terpineol, borneol, caryophyllene, nerolidol, bisabolol and combinations thereof.

111. The method of claim 109, wherein said subject has been diagnosed with dementia or with ASD.

112. A method for treating Tourette’s syndrome in a subject in need thereof, comprising administering to the subject a composition according to claim 4, wherein said cannabinoid is selected from the group consisting of THC, CBD and a combination thereof, wherein said API is selected from the group consisting of a dopamine antagonist, an atypical antipsychotic, a central adrenergic inhibitor, an antidepressant, a benzamide and combinations thereof.

113. The method of claim 112, further comprising administering at least one terpene selected from the group consisting of pinene, myrcene, limonene, linalool, eucalyptol, terpineol, borneol, caryophyllene, nerolidol and combinations thereof.

114. A method for treating endometriosis in a subject in need thereof, comprising administering to the subject a composition according to claim 4, wherein said cannabinoid is selected from the group consisting of THC, CBD and a combination thereof, and wherein said API is selected from the group consisting of a hormone, an analgesic and a combination thereof.

115. The method of claim 114, further comprising administering at least one terpene selected from the group consisting of pinene, myrcene, linalool, limonene, sabinene, terpineol, borneol, geraniol, caryophyllene, nerolidol, bisabolol, humulene and combinations thereof.

116. A method for treating fibromyalgia in a subject in need thereof, comprising administering to the subject a composition according to claim 4, wherein said cannabinoid is selected from the group consisting of THC, CBD and a combination thereof, and wherein said API is selected from the group consisting of an analgesic, an antidepressant, an anticonvulsant and combinations thereof.

117. The method of claim 116, further comprising administering at least one terpene selected from the group consisting of pinene, myrcene, linalool, limonene, sabinene, terpineol, borneol, geraniol, caryophyllene, nerolidol, bisabolol, humulene and combinations thereof.

118. A method of treating osteoarthritis in a subject in need thereof, comprising administering to the subject a composition according to claim 4, wherein said cannabinoid is selected from the group consisting of THC, CBD, CBG, CBC and combinations thereof, and wherein said API comprises an anti-inflammatory analgesic.

119. The method of claim 118, further comprising administering at least one terpene selected from the group consisting of pinene, myrcene, linalool, sabinene, terpineol, borneol, geraniol, caryophyllene, nerolidol, humulene, limonene and combinations thereof and combinations thereof and combinations thereof.

120. A method of treating Amyotrophic Lateral Sclerosis (ALS) in a subject in need thereof, comprising administering to the subject a composition according to claim 4, wherein said cannabinoid is selected from the group consisting of THC, CBG and a combination thereof, and wherein said API comprises riluzole.

121. The method of claim 120, further comprising administering at least one terpene selected from the group consisting of linalool, limonene, eucalyptol, myrcene, caryophyllene, linalool, borneol, sabinene, terpineol, pinene, ocimene, bisabolol and combinations thereof.

122. A method of treating a symptom of multiple sclerosis (MS) in a subject in need thereof, comprising administering to the subject a composition according to claim 4, wherein said cannabinoid is selected from the group consisting of THC, CBD, CBG and combinations thereof, and wherein said API comprises an anti-inflammatory agent.

123. The method of claim 122, further comprising administering at least one terpene selected from the group consisting of pinene, myrcene, caryophyllene, limonene, eucalyptol, linalool, humulene, borneol, sabinene, terpineol, geraniol, nerolidol, bisabolol and combinations thereof.

124. A method of treating Huntington’s disease in a subject in need thereof, comprising administering to the subject a composition according to claim 4, wherein said cannabinoid is selected from the group consisting of THC, CBD, CBG and combinations thereof, and wherein said API is selected from the group consisting of an antipsychotic drug, an antidepressant and an antidyskinetic drug.

125. The method of Claim 124, further comprising administering at least one terpene selected from the group consisting of linalool, limonene, pinene, myrcene, humulene, borneol, sabinene, terpineol, caryophyllene, humulene and combinations thereof.

126. A method of treating osteoporosis in a subject in need thereof, comprising administering to the subject a composition according to claim 4, wherein said cannabinoid comprises CBD and said API is selected from the group consisting of a bisphosphonate, an analgesic and a combination thereof.

127. The method of claim 126, further comprising administering at least one terpene selected from the group consisting of caryophyllene, humulene, carene, camphor, pinene, borneol, limonene, nerolidol and combinations thereof.

128. A method of treating cystic fibrosis in a subject in need thereof, comprising administering to the subject a composition according to claim 4, wherein said cannabinoid is selected from the group consisting of CBD, THC and a combination thereof, and wherein said API is selected from the group consisting of an antibiotic, a mucolytic, a bronchodilator, an anti-inflammatory drug and combinations thereof.

129. The method of claim 128, further comprising administering at least one terpene selected from the group consisting of pinene, limonene, eucalyptol, caryophyllene, sabinene, geraniol, bisabolol, humulene and combinations thereof.

130. A method of treating migraine a subject in need thereof, comprising administering to the subject a composition according to claim 4, wherein said cannabinoid is selected from the group consisting of THC, CBC and a combination thereof, and said API is selected from the group consisting of an analgesic, an SSRI, an ergot alkaloid and combinations thereof.

131. The method of claim 130, further comprising administering at least one terpene selected from the group consisting of caryophyllene, ocimene, terpineol, linalool, limonene, myrcene, borneol, sabinene, pinene, nerolidol, bisabolol and combinations thereof.

132. A method of treating phantom pains in a subject in need thereof, comprising administering to the subject a composition according to claim 4, wherein said cannabinoid comprises THC and wherein said API is selected from the group consisting of an NSAID, an antidepressant, an antispasmodic, a beta blocker, a muscle relaxant and combinations thereof.

133. The method of claim 132, further comprising administering at least one terpene selected from the group consisting of myrcene, linalool, caryophyllene, borneol, terpineol, sabinene, nerolidol, bisabolol and combinations thereof.

134. A method of treating inclusion body myotosis (IBM) in a subject in need thereof, comprising administering to the subject a composition according to claim 4, wherein said API comprises an aminosalicylate, optionally mesalazine.

135. A method of treating Parkinson’s disease in a subject in need thereof, comprising administering to the subject a composition according to claim 4, wherein said API comprises levodopa and optionally carbidopa.

136. A method of treating rheumatoid arthritis in a subject in need thereof, comprising administering to the subject a composition according to claim 4, wherein said API is selected from the group consisting of a steroid, an NSAID and a combination thereof.

137. A method of treating type 2 diabetes in a subject in need thereof, comprising administering to the subject a composition according to claim 4, wherein said cannabinoid comprises CBD and wherein said API comprises metformuine.

138. The method of claim 137, further comprising administering at least one terpene selected from the group consisting of limonene, pinene, linalool, camphene, myrcene, phytol, geraniol, humulene, borneol, eucalyptol and combinations thereof.

139. A method of treating pain in a subject in need thereof, comprising administering to the subject a composition according to claim 4.

140. The method of claim 139, wherein said cannabinoid comprises THC and wherein said API comprises codeine.

141. The method of claim 139, further comprising administering at least one terpene selected from the group consisgint of pinene, myrcene, linalool, limonene, sabinene, terpineol, borneol, geraniol, caryophyllene, nerolidol, bisabolol, humulene and combinations thereof.

142. A method of treating a cough in a subject in need thereof, comprising administering to the subject a composition according to claim 4, wherein said cannabinoid comprises THC and wherein said non-cannabinoid API comprises codeine.

143. A composition comprising at least one cannabinoid for co-administration with at least one non-cannabinoid non-terpene compound selected from the group consisting of anti- oxidants, anti-inflammatory agents, nutraceuticals and combinations thereof, wherein said non- cannabinoid non-terpene compound has a solubility in medium-chain triglycerides (MCT) of at least 10 mcg/ml at 25 ^oC, for use in the treatment of a neurodevelopmental disorder or a neurodegenerative disorder.

144. The composition of claim 143, wherein said neurodevelopmental disorder is selected from the group consisting of autism spectrum disorder (ASD), attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), learning disability, intellectual disability, cerebral palsy, seizures, conduct disorder, communication disorder, neurodevelopmental motor disorder, Alzheimer's disease, dementia, multiple sclerosis, Parkinson's disease, Huntington's disease, motor neuron disease, and amyotrophic lateral sclerosis.

145. A method for treating a neurodevelopment disorder or a neurodegenerative disorder in a subject in need thereof, the method comprising administering to the subject a dose of a composition according to Claim 49.

146. The method of claim 145, wherein said dose comprises from about 0.5 to about 30 mg CBD per 1Kg of body weight per day.

147. The method of Claim 145, wherein said dose comprises 1 to 3000 mcg Vitamin B12.

148. The method of Claim 145, wherein said dose comprises 0.5 to 1000 mcg Vitamin D.

149. The method of Claim 145, wherein said dose comprises 0.1 to 3 gr Omega-3 PUFA.

150. A method for treating acute pain in a subject in need thereof, the method comprising administering to the subject a composition according to claim 4, wherein said at least one cannabinoid comprises between 11 and 40 mg tetrahydrocannabinol (THC) and between 11 and 40 mg cannabidiol (CBD) administered within a 24 period measured from commencement of treatment and said API comprises a non-cannabis non-terpene analgesic at a dose no greater than 90% of a dose of said analgesic required to provide a same effect in the subject in the absence of said THC and CBD.

151. The method of claim 150, wherein said administering is substantially devoid of a non- cannabis non-terpene analgesic.

152. The method of claim 150, further comprising administering at least one terpene selected from the group consisting of pinene, myrcene, sabinene, limonene, linalool, terpineol, eucalyptol, borneol, caryophyllene, humulene, nerolidol, bisabolol and combinations thereof.

153. The method of claim 152, wherein a total terpene to total cannabinoid weight/weight ratio is in the range between 0.05:1 and 1:1.

154. The method of claim 150, comprising administering said analgesic in an amount equivalent to between 1 and 150 mg of morphine.

155. The method of claim 150, wherein said administering of said analgesic is carried out within said 24-hour period.

156. The method of claim 150, wherein said analgesic is administered in a separate dosage form from said THC and/or said CBD.

157. The method of claim 150, wherein said analgesic, said THC and/or said CBD are administered in a single composition.

158. The method of claim 150, wherein said analgesic is an opioid.

159. The method of claim 158, wherein said opioid is morphine.

160. The method of claim 150, wherein said acute pain is selected from the group consisting of acute neuropathic pain, acute radicular pain, acute post-operative pain, acute traumatic pain, acute inflammatory-derived pain and combinations thereof.

161. The method of claim 160, wherein said acute pain is acute neuropathic pain.

162. The method of claim 160, wherein said acute pain is acute radicular pain.

163. The method of claim 150, further comprising administering at least a second dose of said THC and/or said CBD during said 24-hour period.

164. The method of claim 150, wherein said composition is administered once.

165. The method of claim 150, wherein said subject is a male.

166. A composition comprising THC for coadministration with CBD for use in treating acute pain, wherein THC is for administration to the subject at between 11 and 40 mg and CBD is for administration to the subject at between 11 and 40 mg CBD within a 24-period measured from commencement of treatment and no greater than about 90% of the dose of a non-cannabis non-terpene analgesic required to provide the same effect in the subject in the absence of THC and CBD.

167. The composition for use of claim 166, for administration substantially in the absence of administration of a non-cannabis non-terpene analgesic.

168. The composition for use of claim 166, further for co-administration with at least one terpene selected from the group consisting of pinene, myrcene, sabinene, limonene, linalool, terpineol, eucalyptol, borneol, caryophyllene, humulene, nerolidol, bisabolol and combinations thereof.

169. The composition for use of claim 168, wherein a total terpene to total cannabinoid weight/weight ratio is in the range between 0.05:1 and 1:1.

170. The composition for use of claim 166, for co-administration with between 1 and 150 mg of said analgesic.

171. The composition for use of claim 166, wherein said co-administration of said analgesic is carried out within said 24-hour period.

172. The composition for use of claim 166, wherein said analgesic is for administration in a separate dosage form from said THC and/or said CBD.

173. The composition for use of claim 166, wherein said analgesic, said THC and/or said CBD are for co-administration in a single composition.

174. The composition for use of claim 166, wherein said analgesic is an opioid.

175. The composition for use of claim 166, wherein said opioid is morphine.

176. The composition for use of claim 1660, wherein said acute pain is selected from the group consisting of acute neuropathic pain, acute radicular pain, acute post-operative pain, acute traumatic pain, acute inflammatory-derived pain and combinations thereof.

177. The composition for use of claim 166, for further co-administration with at least one additional dose of said CBD within said 24-hour period.

178. The composition for use of claim 166, for a single administration.

179. The composition for use of claim 166, for administration to a male subject.