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Ep 0932416 B1 Europäisches Patentamt *EP000932416B1* (19) European Patent Office Office européen des brevets (11) EP 0 932 416 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.7: A61K 45/06, A61K 31/485, of the grant of the patent: A61K 31/165, A61K 31/135, 22.06.2005 Bulletin 2005/25 A61K 31/00, A61K 31/275 (21) Application number: 97910772.9 (86) International application number: PCT/US1997/017828 (22) Date of filing: 06.10.1997 (87) International publication number: WO 1998/015275 (16.04.1998 Gazette 1998/15) (54) METHOD AND POTENTIATED COMPOSITION FOR TREATING MIGRAINE VERFAHREN UND POTENZIERTE ZUSAMMENSETZUNG ZUR BEHANDLUNG VON MIGRÄNE THERAPIE ET COMPOSITION PHARMACEUTIQUE POTENTIALISEE EFFICACES CONTRE LA MIGRAINE (84) Designated Contracting States: • DHAVARE ET AL: "Effect of Drugs Influencing AT BE CH DE DK ES FI FR GB GR IE IT LI LU MC Central 5-HT Mechanisms on NL PT SE Amantadine-Induced Stereotyped Behaviour in the Rat" INDIAN JOURNAL PHYSIOL. (30) Priority: 09.10.1996 US 727923 PHARMACOL., vol. 27, no. 1, 1983, pages 19-24, 24.10.1996 US 736370 XP002058885 • MAJ T ET AL: "Antagonistic Effect of (43) Date of publication of application: Cyproheptadine on Neuroleptic-Induced 04.08.1999 Bulletin 1999/31 Catalepsy" PHARMACOLOGY BIOCHEMISTRY AND BEHAVIOR, vol. 3, no. 1, 1975, pages 25-27, (73) Proprietor: Algos Pharmaceutical Corporation XP002058886 Neptune, NJ 07753 (US) • SKUZA ET AL: "Memantine, Amantadine and L-Deprenyl Potentiate the Action of L-DOPA in (72) Inventor: CARUSO, Frank, S. Monoamine-Depleted Rats" JOURNAL OF Colts Neck, NJ 07722 (US) NEURAL TRANSMISSION, vol. 98, no. 1, 1994, pages 57-67, XP002058887 (74) Representative: HOFFMANN - EITLE • RABEY ET AL: "Selective Regional Effect of Patent- und Rechtsanwälte Various Neuroactive Drugs on Bromocriptine Arabellastrasse 4 Concentration in the Brain of rats" ACTA 81925 München (DE) NEUROL. SCAND., vol. 74, no. 4, 1986, pages 289-292, XP002058888 (56) References cited: • HOF: "Mutual Inhibition and Synergistic Effects EP-A- 0 615 749 WO-A-92/06726 of Ergotamine and the Calcium Antagonist WO-A-94/08551 WO-A-94/13275 Darodipine" GEN. PHARMACOL., vol. 17, no. 3, WO-A-95/06468 WO-A-95/11240 1986, pages 309-314, XP002058889 WO-A-95/33723 WO-A-96/00073 • BARTOLI ET AL: "Does Lidocaine Affect WO-A-96/27375 DE-A- 4 229 805 Oxidative Dextromethorphan Metabolism In Vivo?" GIORN. ITAL. CHIM. CLIN., vol. 18, no. 2, 1993, pages 125-129, XP002058890 Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention). EP 0 932 416 B1 Printed by Jouve, 75001 PARIS (FR) EP 0 932 416 B1 Description BACKGROUND OF THE INVENTION 5 [0001] This invention relates to a use and composition for treating migraine. More particularly, this invention is con- cerned with alleviating a migraine by administration of an antimigraine drug together with a nontoxic antagonist, or blocker, for the N-methyl-D-aspartate (NMDA) receptor or nontoxic substance that blocks a major intracellular conse- quence of NMDA receptor activation. [0002] The term migraine is defined herein as a severe recurring headache resulting from cerebral vasoconstriction 10 and is classified as either a classical migraine or a common migraine. See, e.g., "Remington's Pharmaceutical Scienc- es", 17th ed., Mack Publishing Company (1985), p. 946 and Goodman and Gilman's "The Pharmaceutical Basis Of Therapeutics", 8th ed., McGraw-Hill, Inc. (1990), pp. 944-947. A common migraine is much more likely to occur than a classical migraine. The classical migraine is associated with objective prodromal neurological signs and symptoms involving a headache that is preceded by a slowly expanding area of blindness surrounded by a sparkling edge that 15 increases to involve up to one half of the field of vision of each eye. When the blindness clears up after approximately 20 minutes, it is often followed by a severe one-sided headache with nausea, vomiting and sensitivity to light. The common migraine is an attack without prodromal symptoms and begins as a slowly developing pain in the form of a headache that transforms into a mounting throbbing pain made worse by the slightest movement or noise. The pain is often on one side of the head only and usually occurs with nausea and sometimes vomiting. 20 [0003] The length of migraine is from about two hours to two days. Examples of causes of migraine are: stress related, e.g., anxiety, anger, worry, excitement, shock, depression, overexertion, changes of routine and changes of climate, food-related, e.g., chocolate, cheese and other dairy products, red wine, fried food and citrus fruits, sensory- related, e.g., bright lights or glare, loud noises and intense or penetrating smells, menstruation and contraceptive drugs. [0004] Antimigraine drugs are well-known. See, e.g., U.S. Patent Nos. 4,650,810, 4,914,125, 4,916,125, 4,994,483, 25 5,021,428, 5,200,413, 5,242,949, 5,248,684, 5,273,759, 5,317,103, 5,364,863, 5,399,574, 5,434,154, 5,441,969, 5,464,864, 5,466,699, 5,468,768, 5,491,148 and 5,494,910. Antimigraine drugs most commonly used in treatment of migraine fall into the following groups: ergot alkaloids, beta-blocking agents, calcium channel blocking agents, antide- pressants, selective 5-HT1 agonists (sumatriptan), sedatives, local anesthetics, adrenergic blocking agents and mix- tures of these. 30 [0005] The antimigraine drugs have direct, or indirect effects on the 5-hydroxytryptamine (5-HT) receptor system. The 5-HT receptor system is a potent intracranial vasoconstrictor. 5-HT receptors are presently delineated into three major subclassifications -5-HT1,5-HT2, and 5-HT3 - each of which may also be heterogeneous. The receptor mediates vasoconstriction in the carotid vascular bed and thereby modifies blood flow therein. The various classes of compounds have been proposed as 5-HT agonists or antagonists for therapeutic use of migraine, but these have not always been 35 specific to a particular type of 5-HT receptor. [0006] Management of migraine is complicated by the lack of a single therapy which is effective in all patients with the same migraine type and by the need to select either an abortive or prophylactic method of treatment for these migraines. Further complications involves the current use of drugs that cause dependence with extended use, such as the ergot alkaloid ergotamine. Another important consideration is that the more effective antimigraine agents in 40 current use, e.g., the ergots, methysergide, produce severe use-limiting side effects with long term usage. [0007] WO-A-9533723 discloses calcium channel antagonists and their use for example to treat migraine. The cal- cium channel antagonists can be combined with one or more other therapeutic agents, such as NMDA antagonists. No particular NMDA antagonists are disclosed. [0008] WO-A-4229805 discloses compositions of one or more calcium channel antagonists, one or more NMDA 45 antagonists, or NMDA antagonists combined with calcium channel antagonists. The compounds cited as calcium chan- nel antagonists are for example memantine, MK-801 or nimodipine. [0009] The combination of the anti-migraine drug L-glutamine with a calcium channel antagonist darodipine is de- scribed by Hof et al., Mutual Inhibition and Synergistic Effects of Ergotamine and the Calcium Antagonist Darodipine, Gen. Pharmac., 1986, Vol. 17, No. 3, pp 309-314. 50 [0010] Thus, there is a need for a safe and effective drug for the treatment of migraine and related disorders which can be used either prophylactically or to alleviate an established migraine. [0011] Heretofore, there has been no recognition or appreciation that the migraine-treating effectiveness of an an- timigraine drug can be appreciably enhanced, or potentiated, by coadministration of this drug with an NMDA receptor antagonist or substance that blocks a major intracellular consequence of NMDA receptor activation. 55 SUMMARY OF THE INVENTION [0012] In accordance with the present invention, a method of alleviating a migraine is provided which comprises 2 EP 0 932 416 B1 coadministering to a mammal exhibiting a migraine (a) a migraine-treating amount of an antimigraine drug and (b) an antimigraine-potentiating amount of at least one member of the group consisting of nontoxic antagonist for the NMDA receptor and nontoxic substance that blocks a major intracellular consequence of NMDA receptor activation. [0013] Further in accordance with this invention, a composition for alleviating migraine is provided which comprises 5 (a) a migraine-treating amount of an antimigraine drug selected from the group consisting of ergot alkaloids, beta- blocking agents, calcium channel blocking agents, antidepressants, selective 5-HT1 agonists (sumatriptan etc.), sed- atives and adrenergic blocking agents and (b) an antimigraine-potentiating amount of at least one member of the group consisting of nontoxic antagonist for the NMDA receptor and nontoxic substance that blocks a major intracellular con- sequence of NMDA receptor activation. 10 [0014] The expression "N-methyl-D-aspartate receptor" shall be understood to include all of the binding site sub- categories associated with the NMDA receptor, e.g., the glycine-binding site, the phenylcyclidine (PCP)-binding site, etc., as well as the NMDA channel. Thus, the invention herein contemplates the use of a nontoxic substance that block an NMDA receptor binding site, i.e., dextrorphan. [0015] The term "nontoxic" as used herein shall be understood in a relative sense and is intended to designate any 15 substance that has been approved by the United States Food and Drug Administration ("FDA") for administration to humans or, in keeping with established regulatory criteria and practice, is susceptible to approval by the FDA for ad- ministration to humans.
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