Claims for Patent: 12,472,257

Summary for Patent: 12,472,257

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:	US19/228,565
Patent Claims:	1. A method of rapidly delivering meloxicam to the blood of a human being comprising orally administering a solid dosage form to a human being in need of treatment of pain, wherein the dosage form comprises meloxicam and a bicarbonate, wherein the bicarbonate is present in the dosage form in an amount of between 50 mg to 250 mg or 350 mg to 850 mg, and wherein the solid dosage form provides a Tmax of meloxicam in the human being that is less than 4 hours. 2. The method of claim 1, wherein the Tmax of meloxicam in the human being is less than 1 hour. 3. The method of claim 1, wherein the Tmax of meloxicam in the human being is between 1-4 hours. 4. The method of claim 1, wherein the Tmax of meloxicam in the human being is between 10 minutes-180 minutes. 5. The method of claim 1, wherein orally administering the solid dosage form achieves a reduction in pain that is observed at less than 15 minutes. 6. The method of claim 1, wherein orally administering the solid dosage form achieves a reduction in pain that is observed at less than 20 minutes. 7. The method of claim 1, wherein orally administering the solid dosage form achieves a reduction in pain that is observed at less than 30 minutes. 8. The method of claim 1, wherein orally administering the solid dosage form achieves a reduction in pain that is observed at less than one hour. 9. The method of claim 1, wherein orally administering the solid dosage form achieves a reduction in pain that lasts at least four hours. 10. The method of claim 1, wherein orally administering the solid dosage form achieves a reduction in pain that lasts at least eight hours. 11. The method of claim 1, wherein orally administering the solid dosage form achieves a reduction in pain that lasts at least twenty-four hours. 12. The method of claim 1, wherein the solid dosage form comprises 1-50 mg meloxicam. 13. The method of claim 1, wherein the solid dosage form comprises 1-15 mg meloxicam. 14. The method of claim 1, wherein the pain is an acute pain. 15. The method of claim 1, wherein the pain is a pain affecting a muscle. 16. The method of claim 1, wherein the pain is a pain affecting a bone. 17. The method of claim 1, wherein the pain is a pain affecting a ligament. 18. The method of claim 1, wherein the pain is a pain affecting a tendon. 19. The method of claim 1, wherein the solid dosage form comprises a cyclodextrin. 20. The method of claim 1, wherein the bicarbonate comprises sodium bicarbonate.