Methods for treatment of headaches by administration of oxytocin

• US 8,198,240 B2
• Filed: 09/15/2008
• Issued: 06/12/2012
• Est. Priority Date: 08/26/2005
• Status: Active Grant

• Current Assignee: HealthPartners Research and Educatio, Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.), Trigemina, Inc.
• Original Assignee: Healthpartners Research Foundation (Health Partners Institute For Education & Research), Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.), Trigemina, Inc.
• Inventors: Yeomans, David C., Angst, Martin S., Frey, William H. II, Jacobs, Daniel I.
• Primary Examiner(s): AUDET, MAURY A
• Application Number:
  US12/210,866
• Publication Number:
  US 20090181880A1
• Time in Patent Office: 1,366 Days
• Field of Search: None
• US Class Current: 514/11.6
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/196 the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
• CPC Class Codes: A61K 38/095 Oxytocins; Vasopressins; Related peptides
• CPC Class Codes: A61K 38/31 Somatostatins
• CPC Class Codes: A61K 38/33 derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/06 Antimigraine agents
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/10 of the posterior pituitary hormones, e.g. oxytocin, ADH

Abstract

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.

Claims

1. A method of treating chronic head or facial pain associated with the trigeminal nerve in an individual in need thereof comprising intranasally administering to an individual in need thereof an effective dose of an oxytocin peptide, wherein the head or facial pain arises from a tension type headache, a vascular type headache, a cluster headache, infection, ingestion of a toxin, overconsumption of alcohol, hydrocephalus, trauma or intracranial disorders.

2. The method according to claim 1, wherein the head or facial pain arises from a cluster headache, a vascular type headache or a tension type headache.

3. The method according to claim 1, wherein the head or facial pain is episodic.

4. The method according to claim 1, wherein the oxytocin peptide is administered to the lower two thirds of the nasal cavity.

5. The method according to claim 1, wherein the effective dose is about 4 IU to about 24 IU.

6. The method according to claim 1, wherein the oxytocin peptide is administered as a pharmaceutical composition.

7. The method according to claim 6, wherein the pharmaceutical composition further comprises at least one additional active agent.

8. The method according to claim 6, wherein the pharmaceutical composition further comprises nociceptin/orphanin FQ.

9. The method according to claim 6, wherein the pharmaceutical composition further comprises an effective therapeutic amount of a vasoconstrictor.

10. The method according to claim 6, wherein the pharmaceutical composition further comprises one or more pharmaceutically acceptable excipients, adjuvants, diluents or stabilizers.

11. The method according to claim 6, wherein the pharmaceutical composition is administered as a powder, a gel, a film, an ointment, a liquid, a suspension, a cream or a bioadhesive.

12. The method according to claim 6, wherein the pharmaceutical composition further comprises at least one protease inhibitor or at least one absorption enhancer.

13. The method according to claim 6, wherein the pharmaceutical composition further comprises at least one protease inhibitor and at least one absorption enhancer.

14. The method according to claim 1, wherein the effective dose is about 0.1 IU to about 150 IU.

15. The method according to claim 1, wherein the effective dose is about 1 IU to about 100 IU.

16. The method according to claim 1, wherein the effective dose is about 10 IU to about 80 IU.

17. The method according to claim 1, wherein administration results in reduction of a pain rating on the VAS of 30% or more.