Claims for Patent: 10,561,664

Summary for Patent: 10,561,664

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:	US16/589,692
Patent Claims:	1. A pharmaceutical dosage form comprising: 1) about 0.0285 mmol to about 0.0854 mmol of meloxicam in a free acid form or a salt form, 2) about 0.0186 mmol to about 0.0557 mmol of rizatriptan in a free base form or a salt form, 3) about 100 mg to about 175 mg of a sulfobutylether-β-cyclodextrin (SBEβCD), and 4) about 400 mg to about 600 mg of sodium bicarbonate. 2. The pharmaceutical dosage form of claim 1, further comprising a starch. 3. The pharmaceutical dosage form of claim 1, further comprising magnesium stearate. 4. The pharmaceutical dosage form of claim 1, comprising about 0.057 mmol of meloxicam in the free acid form or the salt form. 5. The pharmaceutical dosage form of claim 4, comprising about 0.0371 mmol of rizatriptan in the free base form or the salt form. 6. The pharmaceutical dosage form of claim 5, comprising about 120 mg to about 140 mg of the SBEβCD. 7. The pharmaceutical dosage form of claim 6, comprising about 450 mg to about 550 mg of sodium bicarbonate. 8. The pharmaceutical dosage form of claim 7, further comprising a starch. 9. The pharmaceutical dosage form of claim 8, further comprising magnesium stearate. 10. The pharmaceutical dosage form of claim 9, comprising about 0.0371 mmol of rizatriptan in the free base form or the salt form. 11. The pharmaceutical dosage form of claim 1, comprising about 0.0371 mmol of rizatriptan in the free base form or the salt form. 12. The pharmaceutical dosage form of claim 1, comprising about 120 mg to about 140 mg of the SBEβCD. 13. The pharmaceutical dosage form of claim 1, wherein administering the dosage form to a human being results in Tmax of meloxicam that is 120 minutes or less. 14. The pharmaceutical dosage form of claim 1, wherein administering the dosage form to a human being results in a therapeutic plasma concentration of meloxicam being achieved within about 20 minutes. 15. The pharmaceutical dosage form of claim 1, wherein administering the dosage form to a human being results in Tmax of rizatriptan that is less than 60 minutes. 16. A method of treating migraine, comprising administering the dosage form of claim 1 to a human being in need thereof, wherein the human being is free of migraine pain two hours after the dosage form is administered. 17. The method of claim 16, wherein the human being is selected for having a history of inadequate response to prior migraine treatments. 18. The method of claim 16, wherein the human being is experiencing allodynia at the time the dosage form is administered, and the human being is free of allodynia two hours after the dosage form is administered. 19. The method of claim 18, wherein the human being is selected for having a history of inadequate response to prior migraine treatments. 20. The method of claim 16, which provides a greater relief of migraine pain as compared to administering the same amount of rizatriptan in a dosage form that is free of: meloxicam, SBEβCD, and a bicarbonate. 21. The method of claim 16, which provides a greater relief of migraine pain as compared to administering the same amount of meloxicam in a dosage form that is free of: rizatriptan, SBEβCD, and a bicarbonate.