Claims for Patent: 11,471,465

Summary for Patent: 11,471,465

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:	US17/657,546
Patent Claims:	1. A method of treating migraine, comprising orally administering a combination to a human being who is experiencing an acute attack of migraine pain or migraine aura, wherein the combination comprises a meloxicam and about 8 mg to about 13 mg of a rizatriptan, based upon the weight of the free base form of rizatriptan, wherein the combination is in a single dosage form, wherein the single dosage form is structured so that orally administering the single dosage form to healthy human subjects would result in a mean Tmax of meloxicam of 110 minutes or less, and an AUC0-24 of meloxicam of about 30 μg·hr/mL to about 50 μg·hr/mL, and wherein the human being experiences sustained pain relief from 2 hours to 24 hours after the combination is orally administered. 2. The method of claim 1, wherein the human being is instructed to take the combination when the human being is suffering from an acute attack of migraine pain or migraine aura. 3. The method of claim 1, wherein 30 minutes after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would experience 30 minutes after the same amount of the rizatriptan is orally administered alone. 4. The method of claim 1, wherein 2 hours after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would experience 2 hours after the same amount of the rizatriptan is orally administered alone, and 24 hours after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would experience 24 hours after the same amount of the rizatriptan is orally administered alone. 5. The method of claim 1, wherein the human being has a history of inadequate response to prior migraine treatments. 6. The method of claim 1, wherein the human being is selected for having a history of inadequate response to prior migraine treatments. 7. The method of claim 1, wherein the human being has had an average of about 2 to about 8 moderate to severe migraine attacks per month. 8. The method of claim 1, wherein the human being is selected for having an average of about 2 to about 8 moderate to severe migraine attacks per month. 9. The method of claim 1, wherein the meloxicam is complexed with a sulfobutylether-β-cyclodextrin. 10. The method of claim 9, wherein the combination further comprises a bicarbonate. 11. The method of claim 1, wherein the combination further comprises a bicarbonate. 12. The method of claim 10, wherein 1) the complex of the meloxicam and the sulfobutylether-β-cyclodextrin, 2) the bicarbonate, and 3) the rizatriptan, are combined together in a monolayer tablet. 13. The method of claim 10, wherein the combination contains: about 10 mg of rizatriptan in the free base form or a molar equivalent of a salt form; about 20 mg of meloxicam in the free acid form, or a molar equivalent of a salt form; and about 400 mg to about 600 mg of the bicarbonate. 14. The method of claim 13, wherein the bicarbonate is sodium bicarbonate. 15. The method of claim 13, wherein 30 minutes after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would experience 30 minutes after the same amount of the rizatriptan is orally administered alone. 16. The method of claim 15, wherein the human being has a history of inadequate response to prior migraine treatments. 17. The method of claim 15, wherein the human being is selected for having a history of inadequate response to prior migraine treatments. 18. The method of claim 15, wherein 1) the complex of the meloxicam and the sulfobutylether-β-cyclodextrin, 2) the bicarbonate, and 3) the rizatriptan, are combined together in a monolayer tablet. 19. The method of claim 15, wherein 2 hours after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would experience 2 hours after the same amount of the rizatriptan is orally administered alone, and 24 hours after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would experience 24 hours after the same amount of the rizatriptan is orally administered alone. 20. The method of claim 1, wherein the human being does not take any rescue medication for at least 24 hours after the combination is orally administered. 21. The method of claim 1, wherein the human being achieves pain freedom 2 hours after the combination is orally administered. 22. The method of claim 10, wherein the bicarbonate is present in an amount that is effective to increase the dissolution rate of meloxicam. 23. The method of claim 1, wherein the human being is also experiencing nausea. 24. The method of claim 23, wherein 2 hours after the combination is orally administered, the human being experiences a greater reduction in nausea than the human being would experience 2 hours after the same amount of the rizatriptan is orally administered alone. 25. The method of claim 10, wherein the bicarbonate is sodium bicarbonate. 26. The method of claim 11, wherein the bicarbonate is sodium bicarbonate. 27. The method of claim 1, wherein the meloxicam is in the free acid form. 28. The method of claim 1, wherein the rizatriptan is rizatriptan benzoate. 29. The method of claim 1, wherein migraine pain is accompanied by disturbed vision. 30. The method of claim 29, wherein the human being achieves absence of the disturbed vision 2 hours after the combination is orally administered.