Methods for Treatment of Headaches by Administraton of Oxytocin

(19) &

(11) EP 2 179 741 A1

(12) EUROPEAN PATENT APPLICATION

(43) Date of publication: (51) Int Cl.: 28.04.2010 Bulletin 2010/17 A61K 38/04 (2006.01) A61P 25/06 (2006.01) A61K 9/00 (2006.01) A61K 31/00 (2006.01) (2006.01) (2006.01) (21) Application number: 09014456.9 A61K 38/11 A61K 45/06

(22) Date of filing: 28.08.2006

(84) Designated Contracting States: (72) Inventors: AT BE BG CH CY CZ DE DK EE ES FI FR GB GR • Yeomans, David C. HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI Sunnyvale, California 94087 (US) SK TR • Angst, Martin S. Palo Alto, California 94306 (US) (30) Priority: 26.08.2005 US 711950 P • Frey, William H. 21.04.2006 US 794004 P 216, White Bear Lake MN 55127 (US) (62) Document number(s) of the earlier application(s) in • Jacobs, Daniel I. accordance with Art. 76 EPC: Mountain View 06802456.1 / 1 928 484 California 94040 (US)

(71) Applicants: (74) Representative: Sexton, Jane Helen • THE BOARD OF TRUSTEES OF J.A. Kemp & Co. THE LELAND STANFORD JUNIOR UNIVERSITY 14 South Square Palo Alto, CA 94306-1106 (US) Gray’s Inn • Healthpartners Research Foundation London WC1R 5JJ (GB) Bloomington, MN 55425 (US) • Trigemina, Inc. Remarks: Mountain View, CA 94040 (US) This application was filed on 19-11-2009 as a divisional application to the application mentioned under INID code 62.

(54) Methods for treatment of headaches by administraton of oxytocin

(57) The present invention relates to methods for the treatment of headache and headache disorders. The methods comprise administration of an oxytocin peptide for the treatment of primary and secondary headaches or trigeminal neuralgia. EP 2 179 741 A1

Printed by Jouve, 75001 PARIS (FR) (Cont. next page) EP 2 179 741 A1

2 EP 2 179 741 A1

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

5 [0001] The application is related to and claims the benefit of U.S. Provisional Patent Application Serial No. 60/711,950, filed August 26, 2005 and-U.S. Provisional Patent Application Serial No. 60/794,004, filed April 21, 2006, the entire contents of which are hereby incorporated by reference herein in their entirety.

TECHNICAL FIELD 10 [0002] The present invention relates generally to methods and compositions for the treatment of headache and headache or head pain disorders. More specifically, the present invention relates to methods for the treatment or prevention of primary or secondary headaches by administration of oxytocin. In particular, the present invention relates to methods for the treatment or prevention of migraine, cluster, tension headaches or trigeminal neuralgia by administration of 15 oxytocin or pharmaceutical compositions comprising oxytocin to individuals in need of treatment.

BACKGROUND OF THE INVENTION

[0003] Although the epidemiology of headache disorders is only partly documented, taken together, headache disor- 20 ders are extraordinarily common. It has been estimated that worldwide approximately 240 million people have migraine attacks each year. The National Headache Foundation states that more than 29.5 million Americans suffer from migraine headaches, with women being affected three times more often than men. In addition, in developed countries, tension type or "stress" headaches are estimated to affect two- thirds of all adult males and over 80% of adult females. Less well known is the prevalence of chronic daily headaches although the World Health Organization (WHO) estimates that one 25 adult in 20 has a headache every or nearly every day. Trigeminal neuralgia is not a common disorder but the pain associated with trigeminal neuralgia attacks has been described as among the most severe known to mankind. [0004] Not only are headaches painful, but headache disorders can be disabling to afflicted individuals. Worldwide, according to the WHO, when analyzing all causes for "years lived with disability" migraine headaches were rated 19th on the list. Headache disorders may impose substantial har