Treatment of sinusitis related chronic facial pain and headache with botulinum toxin injections

• US 8,691,769 B2
• Filed: 03/08/2004
• Issued: 04/08/2014
• Est. Priority Date: 03/06/2003
• Status: Active Grant

• Current Assignee: Revance Therapeutics, Inc.
• Original Assignee: Botulinum Toxin Research Associates, Inc.
• Inventors: Borodic, Gary, Acquadro, Martin Andrew
• Primary Examiner(s): Kolker, Daniel E
• Application Number:
  US10/793,964
• Publication Number:
  US 20040247606A1
• Time in Patent Office: 3,683 Days
• Field of Search: None
• US Class Current: 514/18.3
• CPC Class Codes: A61K 38/4893 Botulinum neurotoxin (3.4.24.69)
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• 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: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention provides methods for treating sinus-evoked headaches using botulinum toxin injected or applied in multiple subcutaneous locations over divisions of the trigeminal nerve in soft tissues and dermatomes overlying the corresponding effected sinuses implicated in the etiology of the pain.

Claims

1. A method of treating headache and facial pain associated with acute recurrent or chronic sinusitis comprising the steps of selecting a subject suffering from acute recurrent or chronic sinusitis who no longer exhibits sinus inflammation, and administering a therapeutically effective amount of a composition comprising botulinum toxin to the subject'"'"'s nasal mucosa or to the subcutaneous structures overlying the subject'"'"'s sinuses;

wherein the administration of the composition reduces the headache and facial pain associated with acute recurrent or chronic sinusitis.

2. The method of claim 1, wherein the sinuses are one or more of the sinuses selected from the group consisting of:

ethmoid;

maxillary;

mastoid;

frontal; and

sphenoid.

3. The method of claim 2, wherein the subcutaneous structures overlying the sinuses lie within one or more of the areas selected from the group consisting of forehead;

malar;

temporal;

post auricular; and

lip.

4. The method of claim 1, wherein the subcutaneous structures overlying the sinuses lie within one or more of the areas selected from the group consisting of forehead;

malar;

temporal;

post auricular; and

lip.

5. The method of claim 1, wherein the composition is administered to the nasal mucosa.

6. The method of claim 1, wherein the composition is administered at a dose between 15 and 200 mouse LD50 units of botulinum toxin.

7. The method of claim 1, wherein the composition is administered at a dose between 15 and 50,000 mouse LD50 units of botulinum toxin.

8. The method of claim 1, wherein the botulinum toxin is immunotype A.

9. The method of claim 2, wherein the botulinum toxin is immunotype A.

10. The method of claim 4, wherein the botulinum toxin is immunotype A.

11. The method of claim 3, wherein the botulinum toxin is immunotype A.

12. The method of claim 1, wherein the composition is administered by injection.

13. The method of claim 12, wherein there are at least two injection sites.

14. The method of claim 2, wherein the composition is administered by injection.

15. The method of claim 14, wherein there are at least two injection sites.

16. The method of claim 4, wherein the composition is administered by injection.

17. The method of claim 16, wherein there are at least two injection sites.

18. The method of claim 3, wherein the composition is administered by injection.

19. The method of claim 18, wherein there are at least two injection sites.

20. The method of claim 1, wherein the composition is administered to the projections of the trigeminal nerve innervating the sinus.

21. The method of claim 2, wherein the composition is administered to the projections of the trigeminal nerve innervating the sinus.

22. The method of claim 4, wherein the composition is administered to the projections of the trigeminal nerve innervating the sinus.

23. The method of claim 3, wherein the composition is administered to the projections of the trigeminal nerve innervating the sinus.

24. The method of claim 12, wherein the composition is administered to the projections of the trigeminal nerve innervating the sinus.

25. The method of claim 14, wherein the composition is administered to the projections of the trigeminal nerve innervating the sinus.

26. The method of claim 16, wherein the composition is administered to the projections of the trigeminal nerve innervating the sinus.

27. The method of claim 18, wherein the composition is administered to the projections of the trigeminal nerve innervating the sinus.

28. The method of claim 13, wherein the composition is administered to the projections of the trigeminal nerve innervating the sinus.

29. The method of claim 15, wherein the composition is administered to the projections of the trigeminal nerve innervating the sinus.

30. The method of claim 17, wherein the composition is administered to the projections of the trigeminal nerve innervating the sinus.

31. The method of claim 19, wherein the composition is administered to the projections of the trigeminal nerve innervating the sinus.

32. A method of treating headache and facial pain associated with acute recurrent or chronic sinusitis comprising the steps of selecting a subject suffering from acute recurrent or chronic sinusitis who no longer exhibits sinus inflammation, and administering a therapeutically effective amount of a composition comprising botulinum toxin to a location on or within the head of the subject;

wherein the administration of the composition reduces the headache and facial pain associated with acute recurrent or chronic sinusitis.