Method for administering an analgesic

• US 20030138508A1
• Filed: 12/17/2002
• Published: 07/24/2003
• Est. Priority Date: 12/18/2001
• Status: Abandoned Application

• Current Assignee: Alexza Molecular Delivery Corporation (Grupo Ferrer Internacional SA)
• Original Assignee: Alexza Molecular Delivery Corporation (Grupo Ferrer Internacional SA)
• Inventors: Schneider, Stephen A., Novack, Gary D.
• Application Number:
  US10/322,227
• Publication Number:
  US 20030138508A1
• Time in Patent Office: Days
• US Class Current: 424/774
• CPC Class Codes: A61K 31/352 condensed with carbocyclic rings, e.g. methantheline cannabinoids A61K31/658
• CPC Class Codes: A61K 31/4468 having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
• CPC Class Codes: A61K 9/007 Pulmonary tract; Aromatherapy
• CPC Class Codes: A61K 9/0073 Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M

Abstract

A method is provided to parenterally administering an analgesic (i.e., fentanyl) to a patient in the presence of a cannabinoid receptor agonist. This has been found to unexpectedly result in an almost order of magnitude increase in the therapeutic index over that of administering fentanyl alone. The respective amounts of the cannabinoid receptor agonist and fentanyl are selected to achieve the therapeutic index of the analgesic is greater than about 1000. While the method of the present invention contemplates administering the drug by all the medication routes other than orally, the preferred route is via inhalation.

Claims

1. A method of treating pain, wherein the method comprises administering fentanyl and a cannabinoid receptor agonist to a patient, and wherein the fentanyl is administered parenterally, and wherein the amounts of administered fentanyl and cannabinoid receptor agonist are selected such that the therapeutic index of fentanyl in the presence of the cannabinoid receptor agonist is greater than about 1000.

2. The method according to claim 1, wherein the fentanyl is administered intravenously.

3. The method according to claim 1, wherein the fentanyl is administered subcutaneously.

4. The method according to claim 1, wherein the fentanyl is administered intrathecally.

5. The method according to claim 1, wherein the fentanyl is administered transmucosally.

6. The method according to claim 1, wherein the fentanyl is administered transdermally.

7. The method according to claim 1, wherein the fentanyl is administered through inhalation.

8. The method according to claim 1, wherein the cannabinoid receptor agonist is selected from a group consisting of a cannabinoid extract, 11-hydroxy-Δ

⁸-THC-dimethylheptyl, CP 55940, CP 55244, CP 50556, desacetyl-L-nantradol, WIN 55,212-2, and anandamide.

9. The method according to claim 7, wherein the fentanyl is administered as an aerosol, and wherein the aerosol is at least 50 percent by weight of fentanyl.

10. The method according to claim 9, wherein the aerosol is at least 75 percent by weight of fentanyl.

11. The method according to claim 10, wherein the aerosol is at least 90 percent by weight of fentanyl.

12. The method according to claim 11, wherein the aerosol is at least 95 percent by weight of fentanyl.

13. The method according to claim 12, wherein the aerosol is at least 97.5 percent by weight of fentanyl.

14. The method according to claim 1, wherein the cannabinoid receptor agonist is administered through inhalation.

15. The method according to claim 14, wherein the cannabinoid receptor agonist is administered as an aerosol, and wherein the aerosol is at least 50 percent by weight of the cannabinoid receptor agonist.

16. The method according to claim 15, wherein the cannabinoid receptor agonist is administered as an aerosol, and wherein the aerosol is at least 75 percent by weight of the cannabinoid receptor agonist.

17. The method according to claim 16, wherein the cannabinoid receptor agonist is administered as an aerosol, and wherein the aerosol is at least 75 percent by weight of the cannabinoid receptor agonist.

18. The method according to claim 17, wherein the cannabinoid receptor agonist is administered as an aerosol, and wherein the aerosol is at least 90 percent by weight of the cannabinoid receptor agonist.

19. The method according to claim 18, wherein the cannabinoid receptor agonist is administered as an aerosol, and wherein the aerosol is at least 95 percent by weight of the cannabinoid receptor agonist.

20. The method according to claim 19, wherein the cannabinoid receptor agonist is administered as an aerosol, and wherein the aerosol is at least 97.5 percent by weight of the cannabinoid receptor agonist.

21. The method according to claim 8, wherein the cannabinoid extract is selected from the group consisting of cannabis, tetrahydrocannabinol, and cannabis/tetrahydrocannabinol mixtures.

22. The method according to claim 6, wherein the cannabinoid receptor agonist is selected from a group consisting of a cannabinoid extract, 11-hydroxy-Δ

⁸-THC-dimethylheptyl, CP 55940, CP 55244, CP 50556, desacetyl-L-nantradol, WIN 55,212-2, and anandamide.

23. The method according to claim 22, wherein the cannabinoid receptor agonist is tetrahydrocannabinol.

24. The method according to claim 11, wherein the aerosol is formed by heating a composition comprising fentanyl.

25. The method according to claim 24, wherein the composition comprising fentanyl is at least 95 percent by weight of fentanyl.

26. The method according to claim 18, wherein the cannabinoid receptor agonist is tetrahydrocannabinol, and wherein the aerosol is formed by heating a composition comprising tetrahydrocannabinol.

27. The method according to claim 26, wherein the composition comprising tetrahydrocannabinol is at least 95 percent by weight of tetrahydrocannabinol.