[go: up one dir, main page]

EP0948325A2 - Nouveau traitement - Google Patents

Nouveau traitement

Info

Publication number
EP0948325A2
EP0948325A2 EP97953793A EP97953793A EP0948325A2 EP 0948325 A2 EP0948325 A2 EP 0948325A2 EP 97953793 A EP97953793 A EP 97953793A EP 97953793 A EP97953793 A EP 97953793A EP 0948325 A2 EP0948325 A2 EP 0948325A2
Authority
EP
European Patent Office
Prior art keywords
lamotrigine
migraine
pharmaceutically acceptable
treatment
acceptable salt
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.)
Withdrawn
Application number
EP97953793A
Other languages
German (de)
English (en)
Inventor
John Morris SmithKline Beecham Pharm. EVANS
Andrew SmithKline Beecham Pharm PARSONS
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.)
SmithKline Beecham Ltd
Original Assignee
SmithKline Beecham Ltd
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 SmithKline Beecham Ltd filed Critical SmithKline Beecham Ltd
Publication of EP0948325A2 publication Critical patent/EP0948325A2/fr
Withdrawn legal-status Critical Current

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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/53—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine
    • 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
    • A61P25/06—Antimigraine agents

Definitions

  • EP-0021121 (Buroughs Wellcome) describes a class of compounds which are described as being useful for the treatment and/or prevention of epilepsy.
  • One particular compound described therein is 3,5-diamino-6-(2,3-dichlorophenyl)-l,2,4-triazine which is better know as lamotrigine.
  • lamotrigine is particularly useful for treating and/or preventing migraine. Accordingly, the present invention provides the use of lamotrigine and/or pharmaceutically acceptable salts thereof in the manufacture of a medicament in the treatment and/or prevention of migraine.
  • Lamotrigine and/or pharmaceutically acceptable salts thereof may be prepared according to the procedures described in EP-0 021 121.
  • the administration to a sufferer in need thereof may be by way of oral (including sub-lingual) or parenteral administration.
  • a unit dose will normally contain 1 to 1000 mg, suitably 1 to 500 mg, for example an amount in the range of from 2 to 400 mg such as 2, 5, 10, 20, 30, 40, 50, 100, 200, 300 and 400 mg of the active compound.
  • Unit doses will normally be administered once or more than once per day, for example 1, 2, 3, 4, 5 or 6 times a day, more usually 1 to 4 times a day, such that the total daily dose is normally in the range, for a 70 kg adult of 1 to 1000 mg, for example 1 to 500 mg, that is in the range of approximately 0.01 to 15 mg/kg/day, more usually 0.1 to 6 mg/kg/day, for example 1 to 6 mg/kg/day.
  • lamotrigine is administered in the form of a unit-dose composition, such as a unit dose oral (including sub-lingual), rectal, topical or parenteral (especially intravenous) composition.
  • a unit dose oral (including sub-lingual), rectal, topical or parenteral (especially intravenous) composition Such compositions are prepared by admixture and are suitably adapted for oral or parenteral administration, and as such may be in the form of tablets, capsules, oral liquid preparations, powders, granules, lozenges, reconstitutable powders, injectable and infusable solutions or suspensions or suppositories.
  • Orally administrable compositions are preferred, in particular shaped oral compositions, since they are more convenient for general use.
  • Tablets and capsules for oral administration are usually presented in a unit dose, and contain conventional excipients such as binding agents, fillers, diluents, tabletting agents, lubricants, disintegrants, colourants, flavourings, and wetting agents.
  • the tablets may be coated according to well known methods in the art.
  • Suitable fillers for use include cellulose, mannitol, lactose and other similar agents.
  • Suitable disintegrants include starch, polyvinylpyrrolidone and starch derivatives such as sodium starch glycollate.
  • Suitable lubricants include, for example, magnesium stearate.
  • Suitable pharmaceutically acceptable wetting agents include sodium lauryl sulphate.
  • solid oral compositions may be prepared by conventional methods of blending, filling, tabletting or the like. Repeated blending operations may be used to distribute the active agent throughout those compositions employing large quantities of fillers. Such operations are, of course, conventional in the art.
  • Oral liquid preparations may be in the form of, for example, aqueous or oily suspensions, solutions, emulsions, syrups, or elixirs, or may be presented as a dry product for reconstitution with water or other suitable vehicle before use.
  • Such liquid preparations may contain conventional additives such as suspending agents, for example sorbitol, syrup, methyl cellulose, gelatin, hydroxyethylcellulose, carboxymethyl cellulose, aluminium stearate gel or hydrogenated edible fats, emulsifying agents, for example lecithin, sorbitan monooleate, or acacia; non-aqueous vehicles (which may include edible oils), for example, almond oil, fractionated coconut oil, oily esters such as esters of glycerine, propylene glycol, or ethyl alcohol; preservatives, for example methyl or propyl jt?-hydroxybenzoate or sorbic acid, and if desired conventional flavouring or colouring agents.
  • suspending agents for example sorbitol, syrup, methyl cellulose, gelatin, hydroxyethylcellulose, carboxymethyl cellulose, aluminium stearate gel or hydrogenated edible fats, emulsifying agents, for example lecithin, sorbitan monoo
  • Oral formulations also include conventional sustained release formulations, such as tablets or granules having an enteric coating.
  • fluid unit dose forms are prepared containing the compound and a sterile vehicle.
  • the compound depending on the vehicle and the concentration, can be either suspended or dissolved.
  • Parenteral solutions are normally prepared by dissolving the compound in a vehicle and filter sterilising before filling into a suitable vial or ampoule and sealing.
  • adjuvants such as a local anaesthetic, preservatives and buffering agents are also dissolved in the vehicle.
  • the composition can be frozen after filling into the vial and the water removed under vacuum.
  • Parenteral suspensions are prepared in substantially the same manner except that the compound is suspended in the vehicle instead of being dissolved and sterilised by exposure to ethylene oxide before suspending in the sterile vehicle.
  • a surfactant or wetting agent is included in the composition to facilitate uniform distribution of the compound of the invention.
  • the compositions will usually be accompanied by written or printed directions for use in the medical treatment concerned.
  • the present invention further provides a pharmaceutical composition for use in the treatment and/or prophylaxis of migraine which comprises lamotrigine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier.
  • the invention provides a method for the treatment and/or prophylaxis of migraine which comprises administrating an effective or prophylactic amount of lamotrigine to a sufferer in need thereof.
  • compositions may be prepared in the manner as hereinbefore described.
  • the following pharmacological data demonstrates the present invention.
  • CSD was induced by administration of a small quantity (30 mg crystal) of KC1 to a region of the suprasylvian gyrus distant from recording electrodes, vessels under observation and other blood vessels.
  • KC1 dissolves slowly into the brain for the 6 min period of application.
  • the remaining KCl was washed from the brain surface with a saline swab. Changes in extracellular potential and in artery and vein diameter were then recorded for a period of up to 120 min.
  • the compound lamotrigine (10 mg/kg, i.p.) or vehicle (labrasol i.p.) was administered 90 min before CSD induction.
  • Bipolar stainless electrodes were stereotaxically placed into each trigeminal ganglion.
  • Guanethidine (3 mg/kg i.v.) was then administered and 45 min allowed for stabilisation.

Landscapes

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

Abstract

L'invention concerne un procédé de traitement ou de prévention de la migraine chez l'humain. Le procédé consiste à administrer à un patient souffrant de la migraine une quantité effective de lamotrigine ou un sel pharmaceutiquement acceptable dudit produit.
EP97953793A 1996-12-12 1997-12-09 Nouveau traitement Withdrawn EP0948325A2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB9625795 1996-12-12
GBGB9625795.1A GB9625795D0 (en) 1996-12-12 1996-12-12 Novel treatment
PCT/EP1997/006971 WO1998025594A2 (fr) 1996-12-12 1997-12-09 Nouveau traitement

Publications (1)

Publication Number Publication Date
EP0948325A2 true EP0948325A2 (fr) 1999-10-13

Family

ID=10804309

Family Applications (1)

Application Number Title Priority Date Filing Date
EP97953793A Withdrawn EP0948325A2 (fr) 1996-12-12 1997-12-09 Nouveau traitement

Country Status (5)

Country Link
EP (1) EP0948325A2 (fr)
JP (1) JP2001510461A (fr)
CA (1) CA2274858A1 (fr)
GB (1) GB9625795D0 (fr)
WO (1) WO1998025594A2 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK1524981T3 (da) * 2002-07-29 2009-06-22 Glaxo Group Ltd Sammensætninger med vedvarende frigivelse indeholdende lamotrigin
EP1438956A1 (fr) 2003-01-16 2004-07-21 Newron Pharmaceuticals S.p.A. Dérivés alpha-aminoamides en tant qu'agents antimigraine

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9012312D0 (en) * 1990-06-01 1990-07-18 Wellcome Found Pharmacologically active cns compounds
GB9012311D0 (en) * 1990-06-01 1990-07-18 Wellcome Found Pharmacologically active cns compounds
GB9203483D0 (en) * 1992-02-19 1992-04-08 Wellcome Found Anti-inflammatory compounds
US6133299A (en) * 1993-02-25 2000-10-17 Warner-Lambert Company Methods for treating neurodegenerative diseases and disorders using N-(2,6-disubstituted aromatic)-N'-pyridinyl ureas and other anticonvulsant compounds
FR2741879A1 (fr) * 1995-12-05 1997-06-06 Esteve Labor Dr Derives de fluorophenyl-triazines et pyrimidines, leur preparation et leur application en tant que medicament

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9825594A2 *

Also Published As

Publication number Publication date
JP2001510461A (ja) 2001-07-31
CA2274858A1 (fr) 1998-06-18
WO1998025594A2 (fr) 1998-06-18
GB9625795D0 (en) 1997-01-29
WO1998025594A3 (fr) 1998-09-17

Similar Documents

Publication Publication Date Title
US5849763A (en) Use of levobupivacaine as an anesthetic agent
EP0173848B1 (fr) Composés benzopyranniques pour utilisation dans le système cardio-vasculaire
JPS6143113A (ja) 医薬組成物
US4891380A (en) Novel treatment
CA2081344C (fr) Utilisation des antagonistes des recepteurs 5-ht4 pour le traitement des arythmies et des accidents vasculaires cerebraux
EP0821588B1 (fr) Levobupivacaine et son utilisation comme anesthesique chez la femme enceinte
KR100443891B1 (ko) 당뇨병성합병증의예방·치료제
US5049588A (en) Novel treatment for ischemia using an aminotetralin
JP2001515479A (ja) 偏頭痛治療におけるレボブピバカインまたはロピバカインの使用
IE83342B1 (en) Use of a 5-HT4-receptor antagonists in the treatment of atrial fibrillation, including the prevention of stroke
EP0948325A2 (fr) Nouveau traitement
ES2235896T3 (es) Uso de riluzol para el tratamaiento de la esclerosis multiple.
US5162375A (en) Treatment of neuronal degeneration with 5HT1A agonists
HK1004523B (en) Use of 5-ht1a agonists for the manufacture of a medicament protecting against ischaemic damage
US5032596A (en) Treatment of disorders associated with pulmonary hypertension and/or right heart failure
CA2074039C (fr) Preparation medicamenteuse antihypertensive
EP1740176A2 (fr) Compositions pharmaceutiques comprenant des derives de quinazolinecarboxamide anti-inflammatoires
KR20010021796A (ko) 선택성 세로토닌 재흡수 억제제 (ｓｓｒｉ)를 사용하는심장 질환의 치료 및 예방법
CN115475165B (zh) 马来酸茚达特罗在出血性脑损伤相关疾病中的应用
JP2003504396A (ja) マクロライド化合物の新規用途
KR100413717B1 (ko) 레보부피바카인및임산부의마취제로서그것의용도
KR950005869B1 (ko) 위염 치료제
EP0723448A1 (fr) Utilisation de penciclorine dans le traitement des algies post-therapeutiques
JPH0196133A (ja) 脳循環改善剤
JPH03120219A (ja) 治療用組成物

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 19990611

AK Designated contracting states

Kind code of ref document: A2

Designated state(s): BE CH DE ES FR GB IT LI NL

17Q First examination report despatched

Effective date: 20001108

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20010519

REG Reference to a national code

Ref country code: HK

Ref legal event code: WD

Ref document number: 1023067

Country of ref document: HK