HEADACHE TREATMENT METHOD

• US 20100266638A1
• Filed: 06/03/2010
• Published: 10/21/2010
• Est. Priority Date: 02/26/2004
• Status: Abandoned Application

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Brin, Mitchell F., Turkel, Catherine C.
• Application Number:
  US12/793,603
• Publication Number:
  US 20100266638A1
• Time in Patent Office: Days
• US Class Current: 424/239.100
• CPC Class Codes: A61K 35/74 Bacteria therapeutic use of a bacterial protein A61K38/00
• 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 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 21/02 Muscle relaxants, e.g. for tetanus or cramps
• 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 25/24 Antidepressants
• CPC Class Codes: C07K 14/33 from Clostridium (G)
• CPC Class Codes: C12Y 304/24069 Bontoxilysin (3.4.24.69), i.e. botulinum neurotoxin

Abstract

Herein disclosed are methods for treating headache, such as a chronic migraine for example, by administration of botulinum toxin to fixed specific locations of a patient at a fixed amount, as well as optionally administering additional botulinum toxin to a subset of the fixed specific locations of a patient to treat the headache.

Claims

1. A method for treating migraine headache in a patient in need thereof, consisting essentially of:

(a) selecting thirty one administration sites for administration of a botulinum toxin to head/neck areas of the patient, wherein the thirty one administration sites are

(i) four sites of the frontalis,

(ii) two sites of the corrugator,

(iii) one site to the procerus,

(iv) six sites of the occipitalis,

(v) eight sites of the temporalis,

(vi) six sites of the trapezius and

(vii) four sites of the cervical paraspinal,

wherein the selected sites in step (a) to the frontalis, corrugator, occipitalis, temporalis, trapezius and cervical paraspinal muscles are bilaterally distributed with half the number of sites being to the left side and half the number of sites being to the right side of the patient;

(b) optionally selecting additional sites of administration based upon patient-specific symptoms;

wherein additional sites of administration of step (b) are selected from the group consisting of (i) from zero to two additional sites of administration to the temporalis, (ii) from zero to two additional sites of administration to the occipitalis and (ii) from zero to four additional sites of administration to the trapezius muscles are optionally selected; and

(c) administering five units of the botulinum toxin to each of the selected sites, wherein a total amount of botulinum toxin administered is from about one hundred fifty-five units to about one hundred ninety-five units, to thereby treat the migraine headache of the patient.

2. The method of claim 1, wherein no step (b) additional sites of administration are selected.

3. The method of claim 1, wherein at least one step (b) additional site of administration is selected.

4. The method of claim 1, wherein at least two step (b) additional sites of administration are selected and are administered to at least two of the temporalis, occipitalis or trapezius.

5. The method of claim 1, wherein each of the temporalis, occipitalis and trapezius has at least one step (b) additional site of administration selected.

7. The method of claim 1, wherein all step (b) additional sites of administration are selected.

8. The method of claim 1, wherein the patient suffers from headache for at least 15 days out of a 28 day period.

9. The method of claim 1, wherein the botulinum toxin is administered to the patient about every twelve weeks.

10. The method of claim 1, wherein the botulinum toxin is administered transdermally, subcutaneously, intramuscularly or intradermally.

6. The method of step 1, wherein the botulinum toxin is botulinum toxin type A.

11. A method for treating migraine in a patient in need thereof, the method comprising:

administering a therapeutically effective amount of a botulinum toxin bilaterally to the frontalis at four sites of injection;

bilaterally to the corrugator at two sites of injection;

to the procerus at one site of injection, bilaterally to the occipitalis at a minimum of six sites of injection, and up to a maximum of eight sites of injection;

bilaterally to the temporalis at a minimum of eight sites of injection, and up to a maximum of ten sites of injection;

bilaterally to the trapezius at a minimum of six sites of injection, and up to a maximum of ten sites of injection; and

bilaterally to the cervical paraspinal muscles at four sites of injection, to thereby treat the migraine of the patient.

12. The method of claim 11, wherein the botulinum toxin is selected from the group consisting of botulinum toxin type A, B, C, D, E, F and G.

13. The method of claim 11, wherein the botulinum toxin is botulinum toxin type A.

14. The method of claim 11, wherein the botulinum toxin is botulinum toxin type A and is administered:

(a) in an amount of at least twenty units divided evenly among the frontalis four sites of injection;

(b) in an amount of at least ten units divided evenly among the corrugator two sites of injection;

(c) in an amount of at least five units to the procerus at one site of injection;

(d) in an amount of at least thirty units divided evenly among the occipitalis minimum six sites of injection;

(e) in an amount of at least forty units divided evenly among the temporalis minimum eight sites of injection;

(f) in an amount of at least thirty units divided evenly among the trapezius minimum six sites injection; and

(f) in an amount of at least twenty units divided evenly among the cervical paraspinal four sites of injection.

15. The method of claim 11, wherein the patient suffers from headache for at least 15 days out of a 28 day period.

16. The method of claim 11, wherein at least about one hundred and fifty five units of botulinum toxin is administered.

17. A method for treating a migraine in a patient in need thereof, the method comprising the step of administering a minimum amount of a botulinum toxin to the frontalis, corrugator, procerus, occipitalis, temporalis, trapezius and cervical paraspinal muscles of the patient in accordance with the minimum amount of botulinum toxin specified in a package insert;

and, optionally, administering an additional variable amount of botulinum toxin to a subset of the frontalis, corrugator, procerus, occipitalis, temporalis, trapezius and cervical paraspinal muscles of the patient such that the total amount of botulinum toxin administered to the patient does not exceed a maximum total amount specified in the package insert.

18. The method of claim 17, wherein the optional additional variable amount of botulinum toxin is administered to at least one of the temporalis, occipitalis and trapezius muscles of the patient.

19. The method of claim 17, wherein the botulinum toxin is selected from the group consisting of botulinum toxin type A, B, C, D, E, F and G.

20. The method of claim 17, wherein the botulinum toxin is botulinum toxin type A or botulinum toxin type B.