Claims for Patent: 10,195,278

Summary for Patent: 10,195,278

Title:	Pharmaceutical compositions comprising meloxicam
Abstract:	Disclosed herein are compositions comprising an NSAID such as meloxicam 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 conditions such as pain.
Inventor(s):	Herriot Tabuteau
Assignee:	Axsome Therapeutics Inc
Application Number:	US15/986,215
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,195,278
Patent Claims:	1. A method of treating migraine comprising: orally administering a solid dosage form to a human being suffering from a migraine, wherein the solid dosage form comprises: 1) a complex of meloxicam and a sulfobutyl ether β-cyclodextrin (SBEPβCD), and 2) a bicarbonate, wherein orally administering the solid dosage form to the human being results in a Tmax of meloxicam that is shorter than a Tmax of a reference solid dosage form that: 1) contains the same amount of meloxicam, 2) does not contain an SBEβCD, and 3) does not contain a bicarbonate, wherein the solid dosage form has been shown to have a median Tmax of meloxicam that is less than 1 hour in human subjects. 2. The method of claim 1, wherein the solid dosage form contains about 10 mg to about 20 mg of meloxicam. 3. The method of claim 1, wherein the solid dosage form contains about 15 mg of meloxicam. 4. The method of claim 1, wherein the SBEβCD has about 6 to about 7 sulfobutyl ether groups for each molecule of β-cyclodextrin. 5. The method of claim 1, wherein the solid dosage form contains about 50 mg to about 200 mg of the SBEβCD. 6. The method of claim 1, wherein the solid dosage form contains about 100 mg of the SBEβCD. 7. The method of claim 1, wherein the bicarbonate is sodium bicarbonate. 8. The method of claim 1, wherein the solid dosage form contains about 400 mg to about 600 mg of the bicarbonate. 9. The method of claim 7, wherein the solid dosage form contains about 500 mg of sodium bicarbonate. 10. The method of claim 1, wherein the solid dosage form further comprises an acid inhibitor. 11. The method of claim 10, wherein the acid inhibitor is a proton pump inhibitor. 12. The method of claim 11, wherein the proton pump inhibitor is esomeprazole, and about 30 mg to about 50 mg of esomeprazole is present in the solid dosage form. 13. The method of claim 1, wherein the dosage form further comprises rizatriptan. 14. The method of claim 12, wherein the solid dosage form contains about 40 mg of esomeprazole. 15. The method of claim 11, wherein the proton pump inhibitor is esomeprazole, omeprazole, lansoprazole, pantoprazole, or rabeprazole. 16. A method of treating migraine comprising: orally administering a solid dosage form to a human being suffering from a migraine, wherein the solid dosage form comprises: 1) a complex of meloxicam and a sulfobutyl ether β-cyclodextrin (SBEPβCD), and 2) a bicarbonate, wherein orally administering the solid dosage form to the human being results in a Cmax of meloxicam that is at least about 30% higher than a Cmax of a reference solid dosage form that: 1) contains the same amount of meloxicam, 2) does not contain an SBEβCD, and 3) does not contain a bicarbonate. 17. The method of claim 16, wherein the solid dosage form contains about 10 mg to about 20 mg of meloxicam. 18. The method of claim 16, wherein the solid dosage form contains about 15 mg of meloxicam. 19. The method of claim 16, wherein the SBEβCD has about 6 to about 7 sulfobutyl ether groups for each molecule of β-cyclodextrin. 20. The method of claim 16, wherein the solid dosage form contains about 50 mg to about 200 mg of the SBEPβCD. 21. The method of claim 16, wherein the solid dosage form contains about 100 mg of the SBEPβCD. 22. The method of claim 16, wherein the bicarbonate is sodium bicarbonate. 23. The method of claim 16, wherein the solid dosage form contains about 400 mg to about 600 mg of the bicarbonate. 24. The method of claim 22, wherein the solid dosage form contains about 500 mg of sodium bicarbonate. 25. The method of claim 16, wherein the solid dosage form further comprises an acid inhibitor. 26. The method of claim 25, wherein the acid inhibitor is a proton pump inhibitor. 27. The method of claim 26, wherein the proton pump inhibitor is esomeprazole. 28. The method of claim 27, wherein about 30 mg to about 50 mg of esomeprazole is present in the solid dosage form. 29. The method of claim 27, wherein the solid dosage form contains about 40 mg of esomeprazole. 30. The method of claim 16, wherein the dosage form further comprises rizatriptan.