IP Library Granted Patent US 11,628,173
Granted Patent B2
US 11,628,173 · App. 17/934,244 · Granted Apr 18, 2023

Pharmaceutical compositions comprising meloxicam

Inventor: Herriot Tabuteau (New York, NY)
Assignee: AXSOME THERAPEUTICS, INC.
A61K31/5415A61K9/0053A61K9/205A61K9/209A61K9/2009A61K9/2086A61K31/4196A61K47/02A61K47/40A61K47/6951A61P29/00
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 11,628,173
App. No.
17/934,244
Granted
Apr 18, 2023
Kind
B2
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 (19)

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 from about 10 mg to about 15 mg of rizatriptan, or a molar equivalent amount of a salt form of rizatriptan, wherein the human being experiences pain relief at about 2 hours after the tablet is orally administered, and wherein administration of the tablet achieves a reduction in pain that lasts at least about 8 hours.

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 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 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 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 approximately 20 hours for meloxicam.

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

11. The method of claim 10 , wherein, upon orally administering the tablet, the T max of meloxicam in the human being is less than 60 minutes.

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

13. The method of claim 10 , 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.

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

15. The method of claim 10 , wherein, upon orally administering the tablet, the AUC 0-inf of meloxicam in the human being is from about 50,000 ng*hr/mL to about 70,000 ng*hr/mL.

16. The method of claim 10 , wherein, upon orally administering the tablet, the AUC 0-inf of meloxicam in the human being is from about 50,000 ng*hr/mL to about 60,000 ng*hr/mL.

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

18. The method of claim 10 , wherein, upon orally administering the tablet, the mean elimination half-life is approximately 20 hours for meloxicam.

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

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 Oct 6, 2022
From: TABUTEAU, HERRIOT
To: AXSOME THERAPEUTICS, INC.
Reel/Frame 061339/0301 →
Cited By (16)
US 12,268,693 US 12,357,640 US 12,370,196 US 12,472,255 US 12,472,256 US 12,472,257 US 12,472,258 US 12,478,678 US 12,485,176 US 12,544,383 US 12,551,488 US 12,551,489 US 12,611,413 US 12,616,752 US 12,685,736 US 12,691,123