IP Library Granted Patent US 11,617,756
Granted Patent B2
US 11,617,756 · App. 17/723,771 · Granted Apr 4, 2023

Pharmaceutical compositions comprising meloxicam

Inventor: Herriot Tabuteau (New York, NY)
Assignee: AXSOME THERAPEUTICS, INC.
A61K31/5415A61K31/4196A61P25/06
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Quick Facts
Patent No.
US 11,617,756
App. No.
17/723,771
Filed
Apr 19, 2022
Granted
Apr 4, 2023
Kind
B2
Art Unit
1629
USPC
514/226.5
Abstract

Disclosed herein are compositions comprising an NSAID such as meloxicam and/or rizatriptan in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability or pharmacokinetics of the NSAID for the treatment of pain such as migraine, arthritis, and other conditions. Also disclosed herein are methods of treating pain, such as migraine, comprising administering meloxicam and rizatriptan to a human being suffering from pain, such as migraine. For migraine, these methods may be particularly useful when the meloxicam and rizatriptan are administered while the human being is suffering from an acute attack of migraine pain or migraine aura. In some embodiments, the combination of meloxicam and rizatriptan may be administered in a manner that results in a T max of meloxicam of 3 hours or less.

Claims (28)

1. A method of treating migraine, comprising orally administering one tablet daily to a human being in need thereof, wherein the tablet comprises about 20 mg of meloxicam, or a molar equivalent amount of a salt form of meloxicam, and about 10 mg of rizatriptan, or a molar equivalent amount of a salt form of rizatriptan.

2. The method of claim 1 , wherein, upon orally administering the tablet, the T max of meloxicam in the human being is less than 60 minutes.

3. The method of claim 1 , wherein, upon orally administering the tablet, the T max of meloxicam in the human being is about 5×10 1 minutes.

4. The method of claim 1 , wherein, upon orally administering the tablet, the C max of meloxicam in the human being is from about 2,500 ng/mL to about 3,000 ng/mL.

5. The method of claim 1 , wherein, upon orally administering the tablet, the C max of meloxicam in the human being is about 3×10 3 ng/mL.

6. The method of claim 1 , wherein, upon orally administering the tablet, the AUC 0-inf mf of meloxicam in the human being is from about 50,000 ng-hr/mL to about 70,000 ng-hr/mL.

7. The method of claim 1 , wherein, upon orally administering the tablet, the AUC 0-inf mf of meloxicam in the human being is from about 50,000 ng-hr/mL to about 60,000 ng-hr/mL.

8. The method of claim 1 , wherein, upon orally administering the tablet, the AUC 0-inf mf of meloxicam in the human being is about 5×10 4 ng-hr/mL.

9. The method of claim 1 , wherein, upon orally administering the tablet, the mean elimination half-life is about 2×10 1 hours for meloxicam.

10. The method of claim 1 , wherein the tablet comprises about 14 mg of a salt form of rizatriptan.

11. The method of claim 1 , wherein the tablet comprises about 15 mg of a salt form of rizatriptan.

12. The method of claim 1 , wherein the tablet comprises from about 14 mg to about 15 mg of a salt form of rizatriptan.

13. The method of claim 1 , wherein the tablet comprises about 20 mg of the meloxicam.

14. The method of claim 13 , wherein the tablet comprises about 14 mg of a salt form of rizatriptan.

15. The method of claim 13 , wherein the tablet comprises about 15 mg of a salt form of rizatriptan.

16. The method of claim 13 , wherein the tablet comprises from about 14 mg to about 15 mg of a salt form of rizatriptan.

17. The method of claim 1 , wherein the tablet further comprises sodium bicarbonate.

18. The method of claim 9 , wherein the tablet comprises about 20 mg of the meloxicam.

19. The method of claim 18 , wherein the tablet comprises about 14 mg of a salt form of rizatriptan.

20. The method of claim 18 , wherein the tablet comprises about 15 mg of a salt form of rizatriptan.

21. The method of claim 18 , wherein the tablet comprises from about 14 mg to about 15 mg of a salt form of rizatriptan.

22. The method of claim 18 , wherein, upon orally administering the tablet, the T max of meloxicam in the human being is less than 60 minutes.

23. The method of claim 18 , wherein, upon orally administering the tablet, the T max of meloxicam in the human being is about 5×10 1 minutes.

24. The method of claim 18 , wherein, upon orally administering the tablet, the C max of meloxicam in the human being is from about 2,500 ng/mL to about 3,000 ng/mL.

25. The method of claim 18 , wherein, upon orally administering the tablet, the C max of meloxicam in the human being is about 3×10 3 ng/mL.

26. The method of claim 18 , wherein, upon orally administering the tablet, the AUC 0-inf mf of meloxicam in the human being is from about 50,000 ng-hr/mL to about 70,000 ng-hr/mL.

27. The method of claim 18 , wherein, upon orally administering the tablet, the AUC 0-inf mf of meloxicam in the human being is from about 50,000 ng-hr/mL to about 60,000 ng-hr/mL.

28. The method of claim 18 , wherein, upon orally administering the tablet, the AUC 0-inf mf of meloxicam in the human being is about 5×10 4 ng-hr/mL.

Assignments (2)
SECURITY INTEREST Recorded May 9, 2025
From: AXSOME THERAPEUTICS, INC.; AXSOME MALTA LTD.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 071247/0836 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 26, 2022
From: TABUTEAU, HERRIOT
To: AXSOME THERAPEUTICS, INC.
Reel/Frame 059707/0703 →
Continuity (13)
Continuation In Part 17388805 · Jul 29, 2021
Continuation 17205936 · Mar 18, 2021
Continuation In Part 16857435 · Apr 24, 2020
Continuation In Part 16513612 · Jul 16, 2019
Continuation In Part PCTUS2018032162 · May 10, 2018
Continuation In Part PCTUS2018012433 · Jan 4, 2018
Provisional Application 62536466 · Jul 25, 2017
Provisional Application 62526884 · Jun 29, 2017
Provisional Application 62802198 · Feb 6, 2019
Provisional Application 62803756 · Feb 11, 2019
Provisional Application 62835613 · Apr 18, 2019
Provisional Application 62846311 · May 10, 2019
Related Publication 20220241292A1 · Aug 4, 2022
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