Granted Patent
B2
US 12,268,693 · App. 18/674,761 · Granted Apr 8, 2025
Pharmaceutical compositions comprising a tolfenamic acid
Assignee:
AXSOME THERAPEUTICS, INC.
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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 (27)
1. A method of treating migraine, comprising administering to a human being in need thereof a combination of a tolfenamic acid, a rizatriptan, a bicarbonate, and a sulfobutylether-β-cyclodextrin (SBEβCD), wherein the human being is suffering from migraine pain or aura.
2. The method of claim 1 , wherein the combination includes a complex of tolfenamic acid and the SBEβCD.
3. The method of claim 1 , wherein the SBEβCD has about 6 to about 7 sulfobutyl ether groups for each molecule of β-cyclodextrin.
4. The method of claim 1 , wherein the combination contains about 5 mg to about 30 mg of the rizatriptan free base, or a molar equivalent amount of a salt of rizatriptan.
5. The method of claim 4 , wherein the combination contains about 8 mg to about 13 mg of the rizatriptan free base, or a molar equivalent amount of a salt of rizatriptan.
6. The method of claim 5 , wherein the rizatriptan is present as rizatriptan benzoate.
7. The method of claim 1 , wherein the combination contains about 100 mg to about 300 mg of tolfenamic acid in neutral form or a molar equivalent amount of a salt of tolfenamic acid.
8. The method of claim 1 , wherein the combination contains about 200 mg of tolfenamic acid in neutral form or a molar equivalent amount of a salt of tolfenamic acid.
9. The method of claim 7 , wherein the tolfenamic acid is present in the neutral form.
10. The method of claim 7 , wherein the tolfenamic acid is in a sustained release tablet.
11. The method of claim 1 , wherein the combination contains about 50 mg to about 200 mg of the SBEβCD.
12. The method of claim 1 , wherein the combination contains about 400 mg to about 1000 mg of the bicarbonate.
13. The method of claim 1 , wherein the bicarbonate is sodium bicarbonate.
14. The method of claim 13 , wherein the combination contains about 500 mg of sodium bicarbonate.
15. The method of claim 1 , wherein the human being suffers from migraine pain and aura.
16. The method of claim 1 , wherein the combination is orally administered.
17. The method of claim 2 , wherein the combination contains about 10 mg of the rizatriptan free base, or a molar equivalent amount of a salt of rizatriptan.
18. The method of claim 1 , wherein the human being has moderate to severe migraines.
19. The method of claim 1 , wherein administration of the combination improves the bioavailability of tolfenamic acid.
20. The method of claim 1 , wherein the combination is administered in the form of a tablet, a capsule, or an oral suspension.
21. The method of claim 1 , wherein administration of the combination reduces migraine pain in the human being.
22. The method of claim 1 , wherein administration of the combination eliminates migraine pain in the human being.
23. The method of claim 1 , wherein administration of the combination reduces the T max of tolfenamic acid.
24. The method of claim 1 , wherein administration of the combination reduces the T max of rizatriptan.
25. The method of claim 1 , wherein the combination further comprises an acid inhibitor.
26. The method of claim 1 , wherein administration of the combination results in faster release or dissolution of tolfenamic acid.
27. The method of claim 1 , wherein administration of the combination results in faster release or dissolution of rizatriptan.
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 Aug 28, 2024
From: TABUTEAU, HERRIOT
To: AXSOME THERAPEUTICS, INC.
Reel/Frame 068431/0638 →
Continuity (8)
Continuation
PCTUS2021026027
· Apr 6, 2021
Provisional Application
63006023
· Apr 6, 2020
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