Claims for Patent: 10,821,182

Summary for Patent: 10,821,182

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:	US16/867,929
Patent Claims:	1. A method of treating migraine, comprising orally administering a combination of a complex of a meloxicam with sulfobutylether-β-cyclodextrin (SBEβCD), a bicarbonate, and about 8 mg to about 13 mg of a rizatriptan, based upon the weight of the free base form of rizatriptan, to a human being who is suffering from an acute attack of migraine pain or migraine aura, wherein the meloxicam and the rizatriptan are in a single dosage form, wherein administering the combination to the human being results in a 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, wherein the human being has migraine pain that is accompanied with nausea, and wherein two hours after the meloxicam and the rizatriptan are orally administered, the human being experiences greater relief from nausea than the human being would have experienced two hours after receiving the same amount of the rizatriptan orally without the meloxicam. 2. The method of claim 1, wherein the rizatriptan is orally administered in a salt form in an amount that is a molar equivalent to about 10 mg of the free base form of rizatriptan. 3. The method of claim 2, wherein the rizatriptan is present as rizatriptan benzoate. 4. The method of claim 1, wherein about 15 mg to about 25 mg of the meloxicam is orally administered to the human being. 5. The method of claim 1, wherein about 20 mg of the meloxicam is orally administered to the human being. 6. The method of claim 1, wherein the meloxicam is in the free base form. 7. The method of claim 1, wherein the human being has a history of inadequate response to prior migraine treatments. 8. The method of claim 1, wherein the human being is selected for having a history of inadequate response to prior migraine treatments. 9. The method of claim 7, wherein the rizatriptan is orally administered in a salt form in an amount that is a molar equivalent to about 10 mg of the free base form of rizatriptan. 10. The method of claim 7, wherein about 15 mg to about 25 mg of the meloxicam is orally administered to the human being. 11. The method of claim 9, wherein about 20 mg of the meloxicam is orally administered to the human being. 12. The method of claim 1, wherein the human being is instructed to take the combination when the human being is suffering from the acute attack of migraine pain or migraine aura. 13. The method of claim 1, wherein the human being is selected for having nausea with migraine pain. 14. The method of claim 1, wherein two hours after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would have experienced two hours after receiving the same amount of the meloxicam orally without the rizatriptan. 15. The method of claim 1, wherein two hours after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would have experienced two hours after receiving the same amount of the rizatriptan orally without the meloxicam. 16. A method of treating migraine, comprising orally administering a combination of a complex of a meloxicam with sulfobutylether-β-cyclodextrin (SBEβCD), a bicarbonate, and about 8 mg to about 13 mg of a rizatriptan, based upon the weight of the free base form of rizatriptan, to a human being who is suffering from an acute attack of migraine pain or migraine aura, wherein the meloxicam and the rizatriptan are orally administered simultaneously and the meloxicam and rizatriptan are in separate dosage forms, wherein orally administering the combination to the human being results in a 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, wherein the human being has migraine pain that is accompanied with nausea, and wherein two hours after the meloxicam and the rizatriptan are orally administered, the human being experiences greater relief from nausea than the human being would have experienced two hours after receiving the same amount of the rizatriptan orally without the meloxicam. 17. The method of claim 16, wherein the rizatriptan is orally administered in a salt form in an amount that is a molar equivalent to about 10 mg of the free base form of rizatriptan. 18. The method of claim 17, wherein the rizatriptan is present as rizatriptan benzoate. 19. The method of claim 16, wherein about 15 mg to about 25 mg of the meloxicam is orally administered to the human being. 20. The method of claim 16, wherein about 20 mg of the meloxicam is orally administered to the human being. 21. The method of claim 16, wherein the meloxicam is in the free base form. 22. The method of claim 16, wherein the human being has a history of inadequate response to prior migraine treatments. 23. The method of claim 16, wherein the human being is selected for having a history of inadequate response to prior migraine treatments. 24. The method of claim 22, wherein the rizatriptan is orally administered in a salt form in an amount that is a molar equivalent to about 10 mg of the free base form of rizatriptan. 25. The method of claim 22, wherein about 15 mg to about 25 mg of the meloxicam is orally administered to the human being. 26. The method of claim 24, wherein about 20 mg of the meloxicam is orally administered to the human being. 27. The method of claim 16, wherein the human being is instructed to take the combination when the human being is suffering from the acute attack of migraine pain or migraine aura. 28. The method of claim 16, wherein the human being is selected for having nausea with migraine pain. 29. The method of claim 16, wherein two hours after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would have experienced two hours after receiving the same amount of the meloxicam orally without the rizatriptan. 30. The method of claim 16, wherein two hours after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would have experienced two hours after receiving the same amount of the rizatriptan orally without the meloxicam.