Claims for Patent: 11,602,563

Summary for Patent: 11,602,563

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:	US17/837,790
Patent Claims:	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, about 10 mg of rizatriptan, or a molar equivalent amount of a salt form of rizatriptan, and a bicarbonate. 2. The method of claim 1, wherein, upon orally administering the tablet, the Tmax of meloxicam in the human being is less than 60 minutes. 3. The method of claim 1, wherein, upon orally administering the tablet, the Tmax of meloxicam in the human being is about 5×101 minutes. 4. The method of claim 1, wherein, upon orally administering the tablet, the Cmax 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 Cmax of meloxicam in the human being is about 3×103 ng/mL. 6. The method of claim 1, wherein, upon orally administering the tablet, the AUC0-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 AUC0-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 AUC0-inf of meloxicam in the human being is about 5×104 ng*hr/mL. 9. The method of claim 1, wherein, upon orally administering the tablet, the elimination half-life of meloxicam in the human being is approximately 20 hours. 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 bicarbonate 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 Tmax of meloxicam in the human being is less than 60 minutes. 23. The method of claim 18, wherein, upon orally administering the tablet, the Tmax of meloxicam in the human being is about 5×101 minutes. 24. The method of claim 18, wherein, upon orally administering the tablet, the Cmax 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 Cmax of meloxicam in the human being is about 3×103 ng/mL. 26. The method of claim 18, wherein, upon orally administering the tablet, the AUC0-inf 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 AUC0-inf 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 AUC0-inf of meloxicam in the human being is about 5×104 ng*hr/mL. 29. The method of claim 18, wherein, upon orally administering the tablet, the elimination half-life of meloxicam in the human being is approximately 20 hours.