IP Library Granted Patent US 11,865,117
Granted Patent B2
US 11,865,117 · App. 18/051,656 · Granted Jan 9, 2024

Pharmaceutical compositions comprising meloxicam

Inventor: Herriot Tabuteau (New York, NY)
Assignee: AXSOME THERAPEUTICS, INC
A61K31/5415A61K9/0053A61K9/205A61K9/2009A61K31/4196A61P25/06
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Quick Facts
Patent No.
US 11,865,117
App. No.
18/051,656
Filed
Nov 1, 2022
Granted
Jan 9, 2024
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 (24)

1. A method of treating migraine, comprising orally administering a dosage form containing a meloxicam and a rizatriptan to a human being in need thereof, wherein the human being experiences a reduction in pain at about 2 hours after the dosage form is orally administered.

2. The method of claim 1 , wherein the dosage form contains about 8 mg to about 13 mg of the rizatriptan free base, or a molar equivalent amount of a salt of rizatriptan.

3. The method of claim 1 , wherein the human being experiences a reduction in pain at about 30 minutes after the dosage form is orally administered.

4. The method of claim 1 , wherein the human being experiences a reduction in pain at about one hour after the dosage form is orally administered.

5. The method of claim 1 , wherein the human being experiences a reduction in pain at about three hours after the dosage form is orally administered.

6. The method of claim 1 , wherein the human being experiences a reduction in pain at about four hours after the dosage form is orally administered.

7. The method of claim 1 , wherein the human being experiences a reduction in pain at about five hours after the dosage form is orally administered.

8. The method of claim 1 , wherein the dosage form contains about 20 mg of the meloxicam free acid, or a molar equivalent amount of a salt form of meloxicam.

9. The method of claim 1 , wherein the meloxicam is complexed with a cyclodextrin.

10. The method of claim 1 , wherein the dosage form further contains a bicarbonate.

11. The method of claim 1 , wherein the dosage form further contains sodium bicarbonate.

12. The method of claim 1 , wherein, upon orally administering the dosage form, the human being has a T max of meloxicam that is about 120 minutes or less.

13. The method of claim 1 , wherein, upon orally administering the dosage form, the human being has a C max of meloxicam that is about 2500 ng/mL to about 3000 ng/mL.

14. The method of claim 1 , wherein, upon orally administering the dosage form, the human being has an AUC 0-inf of meloxicam that is about 40,000 ng·hr/mL to about 60,000 ng·hr/mL.

15. The method of claim 1 , wherein, upon orally administering the dosage form, the human being has an AUC 0-inf of meloxicam that is about 50,000 ng·hr/mL to about 70,000 ng·hr/mL.

16. The method of claim 1 , wherein, upon orally administering the dosage form, the mean elimination half-life is approximately 20 hours for meloxicam.

17. The method of claim 1 , wherein the human being has acute pain.

18. The method of claim 1 , wherein the dosage form is a tablet.

19. The method of claim 1 , wherein, upon orally administering the dosage form, the human being has a T max of meloxicam that is about 60 minutes or less.

20. The method of claim 19 , wherein the meloxicam is complexed with a cyclodextrin.

21. The method of claim 19 , wherein the dosage form further contains a bicarbonate.

22. The method of claim 19 , wherein the dosage form further contains sodium bicarbonate.

23. The method of claim 1 , wherein the human being experiences a reduction in pain that lasts for at least about 8 hours after the dosage form is orally administered.

24. The method of claim 1 , wherein the human being experiences a reduction in pain that lasts for about 8 to about 24 hours after the dosage form is orally administered.

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 Jan 6, 2023
From: TABUTEAU, HERRIOT
To: AXSOME THERAPEUTICS, INC.
Reel/Frame 062294/0945 →
Continuity (15)
Continuation In Part 17517223 · Nov 2, 2021
Continuation In Part 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
Continuation PCTUS2021026027 · Apr 6, 2021
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
Provisional Application 63006023 · Apr 6, 2020
Related Publication 20230097899A1 · Mar 30, 2023
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