Methods for treating headache

• US 7,704,511 B2
• Filed: 01/11/2006
• Issued: 04/27/2010
• Est. Priority Date: 02/26/2004
• Status: Active Grant

• Current Assignee: Allergan Incorporated (Abbvie Incorporated)
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: Brin, Mitchell F., Turkel, Catherine C.
• Primary Examiner(s): Ford; Vanessa L.
• Application Number:
  US11/329,598
• Publication Number:
  US 20060121057A1
• Time in Patent Office: 1,567 Days
• Field of Search: None
• US Class Current: 424/236.1
• CPC Class Codes: A61K 38/4893 Botulinum neurotoxin (3.4.24.69)
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/06 Antimigraine agents
• CPC Class Codes: A61P 25/08 Antiepileptics; Anticonvulsants
• CPC Class Codes: A61P 25/30 for treating abuse or dependence
• 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: C12Y 304/24069 Bontoxilysin (3.4.24.69), i.e. botulinum neurotoxin

Abstract

The present invention features methods for selecting a patient with an enhanced therapeutic response to a botulinum toxin treatment of a headache. In some embodiments, the methods comprise the step of identifying a patient who is not using a prophylactic headache pain medication, a patient who is overusing an acute pain medication, a patient who suffers four or more hours of headache pain per headache, a patient who has a chronic daily headache for twenty or more years, and/or a patient who has twenty or more headache days out of a 30-day-month.

Claims

1. A method for selecting a patient with an enhanced therapeutic response to botulinum toxin for treating a headache, the method comprising:

a) identifying a patient who suffers from a headache duration of four or more hour per headache, and b) administering from between about 1 and about 2500 units of botulinum toxin to the identified patient, wherein the enhanced response is relative to a patient who suffers less than four hours duration per headache and wherein the patient who suffers four or more hours of headache pain per headache who is being treated with botulinum toxin for a headache experiences at least 2.1 headache-free days out of a 30-day-month more than a patient who suffers less than four hours of headache pain per headache and who is being treated with botulinum toxin for a headache.

2. The method of claim 1, wherein the botulinum toxin is selected from the group consisting of botulinum toxin types A, B, C₁, D, E, F and G.

3. The method of claim 1, wherein the botulinum toxin is a botulinum toxin type A.

4. The method of claim 1, wherein the local administration is by intramuscular or subcutaneous administration to a location on or within a head of a patient.

5. The method of claim 1, wherein the local administration of the botulinum toxin is to a facial muscle of the patient.

6. The method of claim 1, wherein the local administration is to a forehead of the patient.

7. The method of claim 1, wherein the local administration of the botulinum toxin is to a subdermal location or to a muscle location from which the patient perceives a pain to arise.