[go: up one dir, main page]

WO2025006965A1 - Procédés d'administration de solriamfétol à des femmes en lactation - Google Patents

Procédés d'administration de solriamfétol à des femmes en lactation Download PDF

Info

Publication number
WO2025006965A1
WO2025006965A1 PCT/US2024/036129 US2024036129W WO2025006965A1 WO 2025006965 A1 WO2025006965 A1 WO 2025006965A1 US 2024036129 W US2024036129 W US 2024036129W WO 2025006965 A1 WO2025006965 A1 WO 2025006965A1
Authority
WO
WIPO (PCT)
Prior art keywords
solriamfetol
subject
infant
breast milk
disorder
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/036129
Other languages
English (en)
Inventor
Herriot TABUTEAU
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Axsome Therapeutics Inc
Original Assignee
Axsome Therapeutics Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Axsome Therapeutics Inc filed Critical Axsome Therapeutics Inc
Publication of WO2025006965A1 publication Critical patent/WO2025006965A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/27—Esters, e.g. nitroglycerine, selenocyanates of carbamic or thiocarbamic acids, meprobamate, carbachol, neostigmine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • the present invention relates to methods of administering solriamfetol to a lactating subject while reducing the potential for adverse events from solriamfetol in an infant fed breast milk from the subject.
  • Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor that has received marketing approval in the US for improving wakefulness in adult subjects with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA).
  • EDS daytime sleepiness
  • OSA obstructive sleep apnea
  • Solriamfetol has been demonstrated to be useful in the treatment of a variety of disorders, including excessive daytime sleepiness, cataplexy, narcolepsy, fatigue, depression, bipolar disorder, fibromyalgia, and others.
  • the present invention overcomes shortcomings in the art by providing methods of administering solriamfetol to a lactating subject while reducing the potential for adverse events from solriamfetol in an infant fed breast milk from the subject.
  • the present invention relates to the development of methods of reducing the potential for adverse events from solriamfetol in an infant fed breast milk from the subject.
  • the invention additionally related to a method of reducing exposure to solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol.
  • one aspect of the invention relates to a method of reducing exposure to solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby reducing exposure to solriamfetol in the infant.
  • Another aspect of the invention relates to a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: administering solriamfetol orally at a daily dose of between 37.5 mg and 300 mg to the subject; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing the potential for adverse events from solriamfetol in the infant.
  • the daily dose of solriamfetol is 150 mg.
  • An aspect of the invention relates to a method treating a disorder treatable with solriamfetol in a subject producing breast milk for feeding an infant, comprising: administering solriamfetol orally at a daily dose of between 37.5 mg and 300 mg to the subject; and reducing exposure to solriamfetol and/or decreasing the potential for adverse events in the infant fed breast milk from the subject comprising feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject.
  • the disorder treatable with solriamfetol can be, without limitation, narcolepsy, excessive daytime sleepiness, obstructive sleep apnea, attention deficit/hyperactivity disorder, cognitive impairment or binge eating disorder.
  • the method provides a daily infant dose of solriamfetol of about 0.3 mg or lower.
  • the method achieves a relative infant dose of less than about 9% of the subject weight-adjusted dose.
  • the method achieves a relative infant dose of less than about 5% of the subject weight-adjusted dose.
  • the infant does not experience agitation, insomnia, or reduced weight gain due to solriamfetol exposure.
  • the subject is from 1 day to 24 months postpartum or from 10 days to 12 months postpartum.
  • the subject is being treated with solriamfetol for narcolepsy, excessive daytime sleepiness, obstructive sleep apnea, attention deficit/hyperactivity disorder, cognitive impairment, or binge eating disorder.
  • the subject is a woman between the ages of 18 and 45 years.
  • the adverse events are one or more of agitation, insomnia, or reduced weight gain.
  • Methods of treating a disorder amenable to treatment with solriamfetol in a subject who is breastfeeding an infant comprising oraliy administering soiriamfetoi at a daily dose of between about 37.5 mg and 300 mg to the subject.
  • terapéuticaally effective amount refers to that amount of a composition, compound, or agent of this invention that imparts a modulating effect, which, for example, can be a beneficial effect, to a subject afflicted with a disorder, disease or illness, including improvement in the condition of the subject (e.g., in one or more symptoms), delay or reduction in the progression of the condition, prevention or delay of the onset of the disorder, and/or change in clinical parameters, disease or illness, etc., as would be well known in the art.
  • a therapeutically effective amount or effective amount can refer to the amount of a composition, compound, or agent that improves a condition in a subject by at least 5%, e.g., at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, at least 45%, at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, or at least 100%.
  • “Pharmaceutically acceptable carrier’’ refers to a carrier or excipient that is useful in preparing a pharmaceutical or therapeutic composition that is generally safe and non-toxic and includes a carrier that is acceptable for veterinary and/or human pharmaceutical or therapeutic use.
  • carrier or “pharmaceutically acceptable carrier” can include, but are not limited to, phosphate buffered saline solution, water, emulsions (such as an oil/water or water/oil emulsion) and/or various types of wetting agents.
  • carrier encompasses, but is not limited to, any excipient, diluent, filler, salt, buffer, stabilizer, solubilizer, lipid, stabilizer, or other material well known in the art for use in pharmaceutical formulations and as described further herein.
  • modulate refers to enhancement (e.g., an increase) or inhibition (e.g., a decrease) in the specified level or activity.
  • inhibit refers to an increase in the specified parameter of at least about 1.25-fold, 1.5-fold, 2-fold, 3-fold, 4-fold, 5-fold, 6-fold, 8- fold, 10-fold, twelve-fold, or even fifteen-fold and/or can be expressed in the enhancement and/or increase of a specified level and/or activity of at least about 1%, 5%, 10%, 15%, 25%, 35%, 40%, 50%, 60%, 75%, 80%, 90%, 95% or more.
  • “Inhibit” or “reduce” or grammatical variations thereof as used herein refers to a decrease or diminishment in the specified level or activity of at least about 1 , 5, 10, 15%, 25%, 35%, 40%, 50%, 60%, 75%, 80%, 90%, 95% or more. In particular embodiments, the inhibition or reduction results in little or essentially no detectible activity (at most, an insignificant amount, e.g., less than about 10% or even 5%).
  • “Treat,” “treating” and similar terms as used herein in the context of treating a subject refer to providing medical and/or surgical management of a subject. Treatment may include, but is not limited to, administering an agent or composition (e.g., a pharmaceutical composition) to a subject.
  • Treatment is typically undertaken in an effort to alter the course of a disease (which term is used to indicate any disease, disorder, syndrome, or undesirable condition warranting or potentially warranting therapy) in a manner beneficial to the subject.
  • the effect of treatment may include reversing, alleviating, reducing severity of, delaying the onset of, curing, inhibiting the progression of, and/or reducing the likelihood of occurrence or recurrence of the disease or one or more symptoms or manifestations of the disease.
  • a therapeutic agent may be administered to a subject who has a disease or is at increased risk of developing a disease relative to a member of the general population. In some embodiments a therapeutic agent may be administered to a subject who has had a disease but no longer shows evidence of the disease.
  • the agent may be administered e.g., to reduce the likelihood of recurrence of evident disease.
  • a therapeutic agent may be administered prophylactically, i.e., before development of any symptom or manifestation of a disease.
  • “Prophylactic treatment” refers to providing medical and/or surgical management to a subject who has not developed a disease or does not show evidence of a disease in order, e.g., to reduce the likelihood that the disease will occur, delay the onset of the disease, or to reduce the severity of the disease should it occur.
  • the subject may have been identified as being at risk of developing the disease (e.g., at increased risk relative to the general population or as having a risk factor that increases the likelihood of developing the disease.
  • Grammatical variations of “administer,” “administration,” and “administering” to a subject include any route of introducing or delivering to a subject an agent. Administration can be carried out by any suitable route, including oral, topical, intravenous, subcutaneous, transcutaneous, transdermal, intramuscular, intra-joint, parenteral, intra-arteriole, intradermal, intraventricular, intracranial, intraperitoneal, intraiesional, intranasal, rectal, vaginal, by inhalation, via an implanted reservoir, parenteral (e.g., subcutaneous, intravenous, intramuscular, intra-articular, intra- synovial, intrasternal, intrathecal, intraperitoneal, intrahepatic, intraiesional, and intracranial injections or infusion techniques), and the like.
  • parenteral e.g., subcutaneous, intravenous, intramuscular, intra-articular, intra- synovial, intrasternal, intrathecal, intraperitoneal, intrahepatic,
  • Constant administration means that the compounds are administered at the same point in time, overlapping in time, or one following the other. In the latter case, the two compounds are administered at times sufficiently close that the results observed are indistinguishable from those achieved when the compounds are administered at the same point in time.
  • Systemic administration refers to the introducing or delivering to a subject an agent via a route which introduces or delivers the agent to extensive areas of the subject’s body (e.g., greater than 50% of the body), for example through entrance into the circulatory or lymph systems.
  • local administration refers to the introducing or delivery to a subject an agent via a route which introduces or delivers the agent to the area or area immediately adjacent to the point of administration and does not introduce the agent systemically in a therapeutically significant amount.
  • locally administered agents are easily detectable in the local vicinity of the point of administration but are undetectable or detectable at negligible amounts in distal parts of the subject's body.
  • Administration includes self-administration and the administration by another.
  • “Pharmaceutically acceptable,” as used herein, means a material that is not biologically or otherwise undesirable, Le., the material can be administered to an individual along with the compositions of this invention, without causing substantial deleterious biological effects or interacting in a deleterious manner with any of the other components of the composition in which it is contained. The material would naturally be selected to minimize any degradation of the active ingredient and to minimize any adverse side effects in the subject, as would be well known to one of skill in the art (see, e.g., Remington's Pharmaceutical Science; 21st ed. 2005).
  • Concurrently means sufficiently close in time to produce a combined effect (that is, concurrently can be simultaneously, or it can be two or more events occurring within a short time period before or after each other).
  • the administration of two or more compounds “concurrently” means that the two compounds are administered closely enough in time that the presence of one alters the biological effects of the other.
  • the two compounds can be administered in the same or different formulations or sequentially. Concurrent administration can be carried out by mixing the compounds prior to administration, or by administering the compounds in two different formulations, for example, at the same point in time but at different anatomic sites or using different routes of administration.
  • Bioavailability refers to the estimated area under the curve, or AUC of the active drug in systemic circulation after oral administration with a dosage form as disclosed herein when compared with the AUC of the active drug in systemic circulation after intravenous administration of the active drug.
  • the AUC is affected by the extent to which the drug is absorbed in the Gl tract.
  • Products are considered to be “bioequivalent” if the relative mean Cmax, AUC (0-t) and AUC (0- ⁇ ) of the test product to reference product is within 80% to 125%.
  • AUC (0-t) means the area under the plasma concentration curve from time 0 to time t.
  • AUC (0- ⁇ ) or “AUC 0-inf ” means the area under the plasma concentration time curve from time 0 to infinity.
  • TMx refers to the maximum milk or plasma concentration of solriamfetol.
  • T max refers to the time to maximum milk or plasma concentration for a given drug.
  • t 1/2 refers to the time to reduce the milk and plasma concentration by 50% during the terminal elimination phase of the drug.
  • Milk:plasma ratio means AUC in breast milk divided by AUC in plasma.
  • a milk means the amount excreted in breast milk over 72 hours.
  • Vd/F means the apparent volume of distribution in plasma.
  • CL/F is the apparent oral clearance in plasma.
  • AUCO-t is the area under the concentration-time curve from time 0 to the time t of the last quantifiable concentration (milk and plasma).
  • the present invention is based, in part, on methods of using Sunosi® (referred to herein as solriamfetol (also known as (R)-2-amino-3-phenylpropyl carbamate (APC), and previously known as JZP-110, ADX-N05, R228060, and YKP10A)) in lactating subjects with a disorder amenable to treatment with solriamfetol while reducing the potential for adverse effects in infants fed the subject’s breast milk.
  • solriamfetol also known as (R)-2-amino-3-phenylpropyl carbamate (APC), and previously known as JZP-110, ADX-N05, R228060, and YKP10A
  • solriamfetol also known as (R)-2-amino-3-phenylpropyl carbamate (APC), and previously known as JZP-110, ADX-N05, R228060, and
  • solriamfetol was detected in breast milk, with solriamfetol milk concentrations higher than solriamfetol plasma concentrations. It is desirable to reduce or minimize any adverse effects from the daily dose received by an infant fed breast milk from a subject treated with solriamfetol. In addition, it is desirable to identify methods that allow for the safety and tolerability of solriamfetol in nursing subjects.
  • one aspect of the invention relates to a method of reducing exposure to solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby reducing exposure to solriamfetol in the infant.
  • One aspect of the invention comprises methods for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising administering solriamfetol orally at a daily dose of between 37.5 mg and 300 mg to the subject; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing the potential for adverse events from solriamfetol in the infant.
  • the adverse event is one or more of agitation, insomnia, or reduced weight gain.
  • One aspect of the invention relates to a method for treating a disorder treatable with solriamfetol in a subject producing breast milk for feeding an infant, comprising administering solriamfetol orally at a daily dose of between 37.5 mg and 300 mg to the subject; and reducing exposure to solriamfetol and/or decreasing the potential for adverse events in the infant fed breast milk from the subject, comprising feeding the infant breast milk obtained from the subject at least about 5 hours after administering the solriamfetol to the subject.
  • the method reduces solriamfetol in the infant and the infant does not experience agitation, insomnia, or reduced weight gain due to solriamfetol exposure.
  • the adverse events are one or more of agitation, insomnia, or reduced weight gain.
  • a “disorder amenable to treatment with solriamfetol” or a “disorder treatable with solriamfetol” refers to any disorder in which administration of solriamfetol to a subject results in the treatment of one or more symptoms of the disorder in the subject.
  • Example disorders amenable to treatment with solriamfetol include narcolepsy, cataplexy, excessive daytime sleepiness, obstructive sleep apnea, drug addiction, sexual dysfunction, fatigue, fibromyalgia, attention deficit/hyperactivity disorder (ADHD), cognitive impairment and/or cognitive dysfunction, restless legs syndrome, depression, bipolar disorder, obesity, or binge eating disorder.
  • the disorders amenable to treatment with solriamfetol include narcolepsy, excessive daytime sleepiness, obstructive sleep apnea, cognitive impairment, attention deficit/hyperactivity disorder, or binge eating disorder. See, for example, U.S. Patent Nos.
  • EDS Excessive daytime sleepiness
  • a sleep disorder or a symptom of another underlying disorder such as narcolepsy, sleep apnea, circadian rhythm sleep disorder, or idiopathic hypersomnia. While the name includes “daytime,” it is understood that the sleepiness may occur at other times that the subject should be awake, such as nighttime or other times, e.g., if the subject is working nightshift. It is also understood that EDS is medically distinct from fatigue and disorders associated with fatigue.
  • the cause of the EDS may be, without limitation, central nervous system (CNS) pathologic abnormalities, stroke, narcolepsy, idiopathic CNS hypersomnia; sleep deficiency, sleep apnea, obstructive sleep apnea, insufficient nocturnal sleep, chronic pain, acute pain, Parkinson's disease, urinary incontinence, multiple sclerosis fatigue, attention deficit hyperactivity disorder (ADHD), Alzheimer's disorder, major depression, bipolar disorder, cardiac ischemia; misalignments of the body's circadian pacemaker with the environment, jet lag, shift work, or sedating drugs.
  • CNS central nervous system
  • solriamfetol structure is given below as formula I:
  • the methods detailed herein provide an infant fed breast milk from a subject to whom solriamfetol is administered does not experience adverse events, e.g., agitation, insomnia, or reduced weight gain due to solriamfetol exposure.
  • Monitoring the infant for agitation, insomnia, or reduced weight gain can be performed.
  • monitoring and/or detecting weight loss, reduced weight gain, reduction in number of feedings or lessened intake, reduction in volume of milk ingested can be performed.
  • Monitoring increase in agitation and/or insomnia in the infant, including a reduction of sleeping hours and/or time to fall asleep and stay asleep can also be performed to identify changes in the infant.
  • the monitoring for changes in the infant is performed at 3 or more hours subsequent to administering of the solriamfetol dose and subsequent to initiation of infant feeding with breast milk from the subject, for example at 3 hours, 4, hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours or more subsequent to administering of the solriamfetol dose.
  • Monitoring for any changes experienced by the infant e.g., agitation, insomnia, or reduced weight gain
  • the method provides a daily infant dose of solriamfetol of about 0.3 mg or lower, e g., about 0.29 mg, about 0.28 mg, about 0.27 mg, about 0.26 mg, about 0.25 mg, about 0.24 mg, about 0.23 mg, about 0.22 mg, about 0.21 mg, about 0.20 mg, about 0.19 mg, about 0.18 mg, about 0.17 mg, about 0.16 mg, about 0.15 mg, about 0.14 mg, about 0.13 mg, about 0.12 mg, about 0.11 mg, about 0.10 mg, or lower.
  • the daily infant dose means the daily dose that was received by the infant through feeding of breast milk.
  • the method provides a daily infant dose of solriamfetol of about 0.2 mg/kg (based on a nominal infant wight of 6 kg) or lower, e.g., about 0.19 mg/kg, about 0.18 mg/kg, about 0.17 mg/kg, about 0.16 mg/kg, about 0.15 mg/kg, about 0.14 mg/kg, about 0.13 mg/kg, about 0.12 mg/kg, about 0.11 mg/kg, about 0.10 mg/kg, about 0.09 mg/kg, about 0.08 mg/kg, about 0.07 mg/kg, about 0.06 mg/kg, about 0.05 mg/kg, about 0.04 mg/kg, about 0.03 mg/kg, about 0.02 mg/kg, about 0.01 mg/kg, or lower.
  • the method provides a cumulative infant dose of solriamfetol over 72 hours after a single dose of about 0.7 mg or lower, e.g., about 0.69 mg, about 0.68 mg, about 0.67 mg, about 0.66 mg, about 0.65 mg, about 0.64 mg, about 0.63 mg, about 0.62 mg, about 0.61 mg, about 0.60 mg, about 0.59 mg, about 0.58 mg, about 0.57 mg, about 0.56 mg, about 0.55 mg, about 0.54 mg, about 0.53 mg, about 0.52 mg, about 0.51 mg, about 0.50 mg, about 0.49 mg, about 0.48 mg, about 0.47 mg, about 0.46 mg, about 0.45 mg, about 0.44 mg, about 0.43 mg, about 0.42 mg, about 0.41 mg, about 0.40 mg, about 0.39 mg, about 0.38 mg, about 0.37 mg, about 0.36 mg, about 0.35 mg, about 0.34 mg, about 0.33 mg, about 0.32 mg, about 0.31 mg, about 0.30 mg, about 0.29 mg, about 0.28
  • the method provides a total amount of solriamfetol excreted in breast milk after a single dose of about 75%-80% after 8 hours of the total excreted in 72 hours. In some embodiments, the method provides a total amount of solriamfetol excreted in breast milk after a single dose of about 95%- 100% after 24 hours of the total excreted in 72 hours.
  • breast milk for feeding of the infant is expressed or produced from the subject at 3 or more hours, 4 or more hours, or 5 or more hours, for example at 3 hours, 4, hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours or more, subsequent to administering of the solriamfetol dose to the subject.
  • the breast milk produced from the subject for infant feeding in the methods detailed herein occurs at about the mean elimination half-life of soiriamfetol or later, i.e., at about 5 hours, subsequent to administration of the soiriamfetol.
  • the breastfeeding of the infant is performed at 3 or more hours, 4 or more hours, or 5 or more hours subsequent to administering of the soiriamfetol dose to the subject.
  • the breast milk for feeding the infant is obtained from the subject at 3 or more hours, 4 or more hours, or 5 or more hours subsequent to administering of the soiriamfetol dose to the subject.
  • the method achieves a relative infant dose, the percentage of the weight-adjusted subject dose excreted in breast milk over 24 hours, of less than about 10%, less than about 9.5%, less than about 9%, less than about 8.5%, less than about 8%, less than about 7.5%, less than about 7%, less than about 6.5%, less than about 6%, less than about 5.5%, less than about 5%, less than about 4.9%, less than about 4.8%, less than about 4.7%, less than about 4.6%, less than about 4.5%, less than about 4.4%, less than about 4.3%, less than about 4.2%, less than about 4.1%, or about 4.0% of the subject weight-adjusted dose.
  • the method achieves a relative infant dose, the percentage of the weight-adjusted subject dose excreted in breast milk over 72 hours, of less than about 10%, less than about 9.5%, less than about 9%, less than about 8.5%, less than about 8%, less than about 7.5%, less than about 7%, less than about 6.5%, less than about 6%, less than about 5.5%, less than about 5%, less than about 4.9%, less than about 4.8%, less than about 4.7%, less than about 4.6%, less than about 4.5%, less than about 4.4%, less than about 4.3%, less than about 4.2%, less than about 4.1%, or about 4.0% of the subject weight-adjusted dose.
  • the average amount of soiriamfetol that would be passed to an infant feeding from the breast milk produced by the subject treated with soiriamfetol according to the methods disclosed herein is less than about 0.70 mg, about 0.69 mg, about 0.68 mg, about 0.67 mg, about 0.66 mg, about 0.65 mg, about 0.64 mg, about 0.63 mg, about 0.62 mg, about 0.61 mg, about 0.60 mg, or about 0.59 mg over 24 hours.
  • the average amount of solriamfetol that would be passed to an infant feeding from the breast milk produced by the subject treated with solriamfetol according to the methods disclosed herein is less than about 0.70 mg, about 0.69 mg, about 0.68 mg, about 0.67 mg, about 0.66 mg, about 0.65 mg, about 0.64 mg, about 0.63 mg, about 0.62 mg, about 0.61 mg, about 0.60 mg, or about 0.59 mg over 72 hours.
  • a daily dose of about 1 to about 2000 mg of solriamfetol or a pharmaceutically acceptable salt thereof may be administered to accomplish the therapeutic results disclosed herein.
  • a daily dosage of about 1-1000 mg, e.g., about 20-500 mg, in single or divided doses is administered.
  • the daily dose may be about 0.01 to about 150 mg/kg body weight, e.g., about 0.2 to about 18 mg/kg body weight.
  • the dose contains about 1 mg to about 1000 mg of the drug or any range or value therein, e.g., about 10 mg to about 500 mg, e.g., about 37.5 mg, about 75 mg, about 150 mg, or about 300 mg.
  • the total amount of drug may be selected from about 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 225, 250, 275, 300, or any range therein.
  • solriamfetol is administered to the subject as needed to treat a disorder.
  • the compound can be administered continuously or intermittently.
  • the compound is administered to the subject more than once a day, e.g., 2, 3, or 4 times per day, or once every 1, 2, 3, 4, 5, 6, or 7 days.
  • the compound is administered to the subject no more than once a week, e.g., no more than once every two weeks, once a month, once every two months, once every three months, once every four months, once every five months, once every six months, or longer.
  • the compound is administered using two or more different schedules, e.g., more frequently initially (for example to build up to a certain level, e.g., once a day or more) and then less frequently (e.g., once a week or less).
  • the compound can be administered by any discontinuous administration regimen.
  • the compound can be administered not more than once every three days, every four days, every five days, every six days, every seven days, every eight days, every nine days, or every ten days, or longer.
  • the administration can continue for one, two, three, or four weeks or one, two, or three months, or longer.
  • the compound can be administered under the same or a different schedule.
  • the period of rest can be one, two, three, or four weeks, or longer, according to the pharmacodynamic effects of the compound on the subject.
  • the compound can be administered to build up to a certain level, then maintained at a constant level and then a tailing dosage.
  • solriamfetol is delivered to a subject concurrently with an additional therapeutic agent.
  • the additional therapeutic agent can be delivered in the same composition as the compound or in a separate composition.
  • the additional therapeutic agent can be delivered to the subject on a different schedule or by a different route as compared to the compound.
  • the additional therapeutic agent can be any agent that provides a benefit to the subject.
  • Further agents include, without limitation, stimulants, anti-psychotics, antidepressants, agents for neurological disorders, and chemotherapeutic agents.
  • One therapeutic agent that can be administered during the same period is Xyrem®, sold commercially by jazz Pharmaceuticals, which is used to treat narcolepsy and cataplexy. See U.S. Patent Nos. 8,952,062 and 9,050,302.
  • Suitable subjects are generally mammalian subjects.
  • the term “mammal” as used herein includes, but is not limited to, humans, non-human primates, cattle, sheep, goats, pigs, horses, cats, dog, rabbits, rodents (e.g., rats or mice), etc.
  • Human subjects include neonates, infants, juveniles, adults, and geriatric subjects.
  • the subject is postpartum, In some embodiments, the subject is a woman between the ages of 18 and 45 years.
  • Suitable subjects are generally lactating mammalian subjects.
  • mammalian subjects includes, but is not limited to, humans, non-human primates, cattle, sheep, goats, pigs, horses, cats, dog, rabbits, rodents (e.g., rats or mice), etc.
  • the human subject can be a lactating individual who is breastfeeding an infant frequently or on a regular basis.
  • the human subject is a woman. The woman may be between about 18 and 45 years of age.
  • breastfeeding may also be referred to as chestfeeding, or grammatical variations thereof, refers to delivering breast milk of the individual directly to an infant, extracting breast milk from the individual using a device and subsequently delivering to an infant, extracting breast milk from the individual using a device and storing the breast milk for a period of time and subsequently delivering the stored breast milk to the infant, or a combination thereof.
  • the subject of the present disclosure can be in lactation, for example, an individual who is lactating (e.g., producing breast milk), nursing or breastfeeding.
  • the subject can be in lactation after pregnancy, i.e., post-partum, or via induced lactation (e.g., with metoclopramide, oral contraceptives, herbal medications, stimulation via pumping, or any combination thereof.).
  • the subject is between 1 day and 24 months postpartum, between about 1 day and 12 months postpartum, or between about 10 days and 12 months postpartum.
  • the subject expresses mature milk, which typically occurs about 10 to about 30 days (e.g., about 10 days, about 11 days, about 12 days, about 13 days, about 14 days, about 15 days, about 16 days, about 17 days, about 18 days, about 19 days, about 20 days, about 21 days, about 22 days, about 23 days, about 24 days, about 25 days, about 26 days, about 27 days, about 28 days, about 29 days, about 30 days) postpartum, or about 10 to about 20 days postpartum, or about 10 to about 20 days after beginning of milk expression in induced lactation. Infancy starts at birth and ends around the age of 2 years; accordingly, the infant stage being fed breast milk includes the breastfeeding period.
  • the subject can be a subject “in need of’ the methods of the present invention, e.g., in need of the therapeutic effects of the inventive methods.
  • the subject can be a subject that is experiencing a disorder amenable to treatment with solriamfetol, is suspected of having a disorder amenable to treatment with solriamfetol, and/or is anticipated to experience a disorder amenable to treatment with solriamfetol, and the methods and compositions of the invention are used for therapeutic and/or prophylactic treatment.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Emergency Medicine (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Selon certains modes de réalisation, l'invention concerne un procédé destiné à diminuer le potentiel d'événements indésirables causés par du solriamfétol dans un lait maternel, ingéré par un nourrisson, obtenu d'un sujet traité avec du solriamfétol comprenant : l'administration orale du solriamfétol au sujet à une dose quotidienne d'environ 37,5 mg à environ 300 mg ; et l'ingestion du lait maternel infantile du sujet au moins environ 5 heures après l'administration du solriamfétol au sujet, ce qui permet de diminuer le potentiel d'événements indésirables causés par du solriamfétol chez un nourrisson.
PCT/US2024/036129 2023-06-29 2024-06-28 Procédés d'administration de solriamfétol à des femmes en lactation Pending WO2025006965A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202363510981P 2023-06-29 2023-06-29
US63/510,981 2023-06-29
US202363592313P 2023-10-23 2023-10-23
US63/592,313 2023-10-23

Publications (1)

Publication Number Publication Date
WO2025006965A1 true WO2025006965A1 (fr) 2025-01-02

Family

ID=92107006

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/036129 Pending WO2025006965A1 (fr) 2023-06-29 2024-06-28 Procédés d'administration de solriamfétol à des femmes en lactation

Country Status (1)

Country Link
WO (1) WO2025006965A1 (fr)

Citations (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5705640A (en) 1995-02-11 1998-01-06 Yukong Limited O-carbamoyl-(d)-phenylalaninol compounds, their pharmaceutically useful salts and process for preparing the same
US5756817A (en) 1995-02-11 1998-05-26 Yukong Limited O-carbamoyl-phenylalaninol compounds, their pharmaceutically useful salts and process for preparing the same
US5955499A (en) 1994-09-09 1999-09-21 Yukong Limited Phenylalkylaminoalcohol carbamates and process for preparing the same
US6140532A (en) 1995-04-10 2000-10-31 Sk Corporation O-carbamoyl-phenylalaninol having substituent at benzene ring, its pharmaceutically useful salts and method for preparing the same
US20120004300A1 (en) 2010-06-30 2012-01-05 Sk Holdings Co., Ltd. Methods for treating bipolar disorder
US8232315B2 (en) 2009-06-26 2012-07-31 Sk Biopharmaceuticals Co., Ltd. Methods for treating drug addiction and improving addiction-related behavior
US8440715B2 (en) 2005-06-08 2013-05-14 Sk Biopharmaceuticals Co., Ltd. Treatment of sleep-wake disorders
US8552060B2 (en) 2005-06-22 2013-10-08 Sk Biopharmaceuticals Co., Ltd. Methods for treatment of sexual dysfunction
US8623913B2 (en) 2010-06-30 2014-01-07 Sk Biopharmaceuticals Co., Ltd. Methods for treating restless legs syndrome
US8729120B2 (en) 2004-10-28 2014-05-20 Sk Biopharmaceuticals Co., Ltd. Adjunctive therapy for depression
US8741950B2 (en) 2009-06-22 2014-06-03 Sk Biopharmaceuticals Co., Ltd. Methods for treating or preventing fatigue
US8895609B2 (en) 2009-11-06 2014-11-25 Sk Biopharmaceuticals Co., Ltd. Methods for treating attention-deficit/hyperactivity disorder
US8927602B2 (en) 2009-11-06 2015-01-06 Sk Biopharmaceuticals Co., Ltd. Methods for treating fibromyalgia syndrome
US20150018414A1 (en) 2013-07-12 2015-01-15 Jazz Pharmaceuticals International lll Limited Promotion of Smoking Cessation
US8952062B2 (en) 1998-12-23 2015-02-10 Jazz Pharmaceuticals, Inc. Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
US9050302B2 (en) 2013-03-01 2015-06-09 Jazz Pharmaceuticals Ireland Limited Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
US9226910B2 (en) 2013-07-18 2016-01-05 Jazz Pharmaceuticals International Iii Limited Treatment for obesity
US9359290B2 (en) 2013-03-13 2016-06-07 Jazz Pharmaceuticals International Iii Limited Treatment of cataplexy
US10829443B2 (en) 2016-09-06 2020-11-10 Jazz Pharmaceuticals Ireland Limited Solvate form of (R)-2-amino-3-phenylpropyl carbamate
US11771667B1 (en) * 2022-12-30 2023-10-03 Axsome Malta Ltd. Methods of administering solriamfetol to lactating women
WO2024145545A2 (fr) * 2022-12-30 2024-07-04 Axsome Malta Ltd. Procédés d'administration de solriamfétol à des femmes en lactation

Patent Citations (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5955499A (en) 1994-09-09 1999-09-21 Yukong Limited Phenylalkylaminoalcohol carbamates and process for preparing the same
US5705640A (en) 1995-02-11 1998-01-06 Yukong Limited O-carbamoyl-(d)-phenylalaninol compounds, their pharmaceutically useful salts and process for preparing the same
US5756817A (en) 1995-02-11 1998-05-26 Yukong Limited O-carbamoyl-phenylalaninol compounds, their pharmaceutically useful salts and process for preparing the same
US5705640C1 (en) 1995-02-11 2001-03-20 Sk Corp O-carbamoyl-(d)-phenylalaninol compounds heir pharmaceutically useful salts and process for preparing the same
US5756817C1 (en) 1995-02-11 2001-04-17 Sk Corp O-carbamoyl-phenylananinol compounds their pharmaceutically useful salts and process for preparing the same
US6140532A (en) 1995-04-10 2000-10-31 Sk Corporation O-carbamoyl-phenylalaninol having substituent at benzene ring, its pharmaceutically useful salts and method for preparing the same
US8952062B2 (en) 1998-12-23 2015-02-10 Jazz Pharmaceuticals, Inc. Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
US8729120B2 (en) 2004-10-28 2014-05-20 Sk Biopharmaceuticals Co., Ltd. Adjunctive therapy for depression
US8440715B2 (en) 2005-06-08 2013-05-14 Sk Biopharmaceuticals Co., Ltd. Treatment of sleep-wake disorders
US8552060B2 (en) 2005-06-22 2013-10-08 Sk Biopharmaceuticals Co., Ltd. Methods for treatment of sexual dysfunction
US8741950B2 (en) 2009-06-22 2014-06-03 Sk Biopharmaceuticals Co., Ltd. Methods for treating or preventing fatigue
US8232315B2 (en) 2009-06-26 2012-07-31 Sk Biopharmaceuticals Co., Ltd. Methods for treating drug addiction and improving addiction-related behavior
US8927602B2 (en) 2009-11-06 2015-01-06 Sk Biopharmaceuticals Co., Ltd. Methods for treating fibromyalgia syndrome
US8895609B2 (en) 2009-11-06 2014-11-25 Sk Biopharmaceuticals Co., Ltd. Methods for treating attention-deficit/hyperactivity disorder
US8623913B2 (en) 2010-06-30 2014-01-07 Sk Biopharmaceuticals Co., Ltd. Methods for treating restless legs syndrome
US20120004300A1 (en) 2010-06-30 2012-01-05 Sk Holdings Co., Ltd. Methods for treating bipolar disorder
US9050302B2 (en) 2013-03-01 2015-06-09 Jazz Pharmaceuticals Ireland Limited Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
US9359290B2 (en) 2013-03-13 2016-06-07 Jazz Pharmaceuticals International Iii Limited Treatment of cataplexy
US20150018414A1 (en) 2013-07-12 2015-01-15 Jazz Pharmaceuticals International lll Limited Promotion of Smoking Cessation
US9226910B2 (en) 2013-07-18 2016-01-05 Jazz Pharmaceuticals International Iii Limited Treatment for obesity
US10829443B2 (en) 2016-09-06 2020-11-10 Jazz Pharmaceuticals Ireland Limited Solvate form of (R)-2-amino-3-phenylpropyl carbamate
US11771667B1 (en) * 2022-12-30 2023-10-03 Axsome Malta Ltd. Methods of administering solriamfetol to lactating women
WO2024145545A2 (fr) * 2022-12-30 2024-07-04 Axsome Malta Ltd. Procédés d'administration de solriamfétol à des femmes en lactation

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "Joint Supervisory Review of Sunosi / solriamfetol", U.S. FOOD AND DRUGS ADMINISTRATION; CENTER FOR DRUG EVALUATION AND RESEARCH, 20 March 2019 (2019-03-20), XP093182206, Retrieved from the Internet <URL:https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211230Orig1Orig2s000SumR.pdf> [retrieved on 20240704] *
ANONYMOUS: "NCT05008341: Evaluate Sunosi? PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration", CLINICALTRIALS.GOV, 14 April 2023 (2023-04-14), XP093208755, Retrieved from the Internet <URL:https://clinicaltrials.gov/study/NCT05008341?term=NCT05008341&rank=1> [retrieved on 20240925] *
REMINGTON'S PHARMACEUTICAL SCIENCE, 2005

Similar Documents

Publication Publication Date Title
JP2022003085A (ja) 神経変性疾患のための治療薬
US11771667B1 (en) Methods of administering solriamfetol to lactating women
AU2018219861B2 (en) Methods of treating seizure disorders and prader-willi syndrome
WO2006053186A2 (fr) Methode de traitement de troubles moteurs
KR20250129075A (ko) 수유 여성에게 솔리암페톨을 투여하는 방법
KR102549684B1 (ko) 신경퇴행성 질병에 대한 치료제
WO2025006965A1 (fr) Procédés d&#39;administration de solriamfétol à des femmes en lactation
US12064411B1 (en) Methods of administering solriamfetol to lactating women
US20240350435A1 (en) Methods of administering solriamfetol to lactating women
US20170196824A1 (en) Compositions and methods of use of beta-hydroxy-beta-methylbutyrate (hmb) for joint stability
CN111712239A (zh) 治疗不宁腿综合征的治疗剂
EP4518848A1 (fr) Baclofène intranasal
US12005036B1 (en) Methods of administering solriamfetol to lactating women
US12263145B2 (en) Methods of administering solriamfetol to lactating women
US12090126B2 (en) Methods of administering solriamfetol to lactating women
US12036194B1 (en) Methods of administering solriamfetol to lactating women
KR20230159462A (ko) 수면 무호흡증 치료 방법 및 조성물
Yoshino et al. Use of Gabapentin for Paroxysmal Sympathetic Hyperactivity in Three Children with Severe Motor and Intellectual Disability due to Neonatal Hypoxic Ischemic Encephalopathy
US20210077439A1 (en) Compositions and methods of use of beta-hydroxy-beta-methylbutyrate (hmb) for joint stability
WO2025162430A1 (fr) Combinaison de médicaments et son utilisation dans la prévention ou le traitement d&#39;une maladie neurodégénérative
WO2009140575A1 (fr) Utilisation de ribose dans la diminution des symptômes cliniques de l&#39;activation aberrante des neurones

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 24748473

Country of ref document: EP

Kind code of ref document: A1