Claims for Patent: 11,865,117

Summary for Patent: 11,865,117

Title:	Pharmaceutical compositions comprising meloxicam
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 Tmax of meloxicam of 3 hours or less.
Inventor(s):	Herriot Tabuteau
Assignee:	Axsome Therapeutics Inc
Application Number:	US18/051,656
Patent Claims:	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 Tmax 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 Cmax 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 AUC0-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 AUC0-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 Tmax 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.