Claims for Patent: 10,688,102

Summary for Patent: 10,688,102

Title:	Combination treatment for migraine and other pain
Abstract:	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:	US16/513,612
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,688,102
Patent Claims:	1. A method of treating migraine, comprising administering a meloxicam 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 administered within about 30 minutes of one another, wherein administering the meloxicam 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, and wherein two hours after the meloxicam and the rizatriptan are 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 meloxicam without the rizatriptan. 2. The method of claim 1, wherein the rizatriptan is 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 administered to the human being. 5. The method of claim 1, wherein about 20 mg of the meloxicam is administered to the human being. 6. The method of claim 1, wherein the human being has a history of inadequate response to prior migraine treatments. 7. The method of claim 6, wherein the rizatriptan is administered in a salt form in an amount that is a molar equivalent to about 10 mg of the free base form of rizatriptan. 8. The method of claim 6, wherein about 15 mg to about 25 mg of the meloxicam is administered to the human being. 9. The method of claim 7, wherein about 20 mg of the meloxicam is administered to the human being. 10. The method of claim 1, wherein the meloxicam and the rizatriptan are administered simultaneously, and wherein two hours after the meloxicam and the rizatriptan are administered, the human being experiences greater pain relief than the human being would have experienced two hours after receiving the same amount of the meloxicam without the rizatriptan. 11. The method of claim 10, wherein the rizatriptan is administered in a salt form in an amount that is a molar equivalent to about 10 mg of the free base form of rizatriptan. 12. The method of claim 10, wherein about 15 mg to about 25 mg of the meloxicam is administered to the human being. 13. The method of claim 11, wherein about 20 mg of the meloxicam is administered to the human being. 14. The method of claim 1, wherein the meloxicam and the rizatriptan are administered simultaneously, and wherein two hours after the meloxicam and the rizatriptan are administered, the human being experiences greater pain relief than the human being would have experienced two hours after receiving the same amount of the rizatriptan without the meloxicam. 15. The method of claim 14, wherein the rizatriptan is administered in a salt form in an amount that is a molar equivalent to about 10 mg of the free base form of rizatriptan. 16. The method of claim 14, wherein about 15 mg to about 25 mg of the meloxicam is administered to the human being. 17. The method of claim 15, wherein about 20 mg of the meloxicam is administered to the human being. 18. The method of claim 1, wherein the meloxicam and the rizatriptan are administered simultaneously, and wherein two hours after the meloxicam and the rizatriptan are 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 meloxicam without the rizatriptan. 19. A method of treating migraine, comprising administering a meloxicam 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 administered within about 30 minutes of one another, wherein administering the meloxicam 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, and wherein two hours after the meloxicam and the rizatriptan are 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 without the meloxicam. 20. A method of treating migraine, comprising administering a meloxicam 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 administered within about 30 minutes of one another, wherein administering the meloxicam 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, and wherein two hours after the meloxicam and the rizatriptan are administered, the human being experiences greater relief from vomiting than the human being would have experienced two hours after receiving the same amount of the meloxicam without the rizatriptan. 21. A method of treating migraine, comprising administering a meloxicam 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 administered within about 30 minutes of one another, wherein administering the meloxicam 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, and wherein two hours after the meloxicam and the rizatriptan are administered, the human being experiences greater relief from vomiting than the human being would have experienced two hours after receiving the same amount of the rizatriptan without the meloxicam. 22. A method of treating migraine, comprising administering a meloxicam 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 administered within about 30 minutes of one another, wherein administering the meloxicam 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, and wherein two hours after the meloxicam and the rizatriptan are administered, the human being experiences greater relief from photophobia than the human being would have experienced two hours after receiving the same amount of the meloxicam without the rizatriptan. 23. A method of treating migraine, comprising administering a meloxicam 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 administered within about 30 minutes of one another, wherein administering the meloxicam 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, and wherein two hours after the meloxicam and the rizatriptan are administered, the human being experiences greater relief from photophobia than the human being would have experienced two hours after receiving the same amount of the rizatriptan without the meloxicam. 24. A method of treating migraine, comprising administering a meloxicam 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 administered within about 30 minutes of one another, wherein administering the meloxicam 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, and wherein two hours after the meloxicam and the rizatriptan are administered, the human being experiences greater relief from phonophobia than the human being would have experienced two hours after receiving the same amount of the meloxicam without the rizatriptan. 25. A method of treating migraine, comprising administering a meloxicam 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 administered within about 30 minutes of one another, wherein administering the meloxicam 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, and wherein two hours after the meloxicam and the rizatriptan are administered, the human being experiences greater relief from phonophobia than the human being would have experienced two hours after receiving the same amount of the rizatriptan without the meloxicam. 26. The method of claim 19, wherein the rizatriptan is administered in a salt form in an amount that is a molar equivalent to about 10 mg of the free base form of rizatriptan. 27. The method of claim 26, wherein the rizatriptan is present as rizatriptan benzoate. 28. The method of claim 19, wherein about 15 mg to about 25 mg of the meloxicam is administered to the human being. 29. The method of claim 19, wherein about 20 mg of the meloxicam is administered to the human being. 30. The method of claim 19, wherein the human being has a history of inadequate response to prior migraine treatments. 31. The method of claim 30, wherein the rizatriptan is administered in a salt form in an amount that is a molar equivalent to about 10 mg of the free base form of rizatriptan. 32. The method of claim 30, wherein about 15 mg to about 25 mg of the meloxicam is administered to the human being. 33. The method of claim 31, wherein about 20 mg of the meloxicam is administered to the human being. 34. The method of claim 19, wherein the meloxicam and the rizatriptan are administered simultaneously, and wherein two hours after the meloxicam and the rizatriptan are 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 meloxicam without the rizatriptan. 35. The method of claim 34, wherein the rizatriptan is administered in a salt form in an amount that is a molar equivalent to about 10 mg of the free base form of rizatriptan. 36. The method of claim 34, wherein about 15 mg to about 25 mg of the meloxicam is administered to the human being. 37. The method of claim 35, wherein about 20 mg of the meloxicam is administered to the human being. 38. The method of claim 19, wherein the meloxicam and the rizatriptan are administered simultaneously, and wherein two hours after the meloxicam and the rizatriptan are 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 without the meloxicam. 39. The method of claim 38, wherein the rizatriptan is administered in a salt form in an amount that is a molar equivalent to about 10 mg of the free base form of rizatriptan. 40. The method of claim 38, wherein about 15 mg to about 25 mg of the meloxicam is administered to the human being. 41. The method of claim 39, wherein about 20 mg of the meloxicam is administered to the human being. 42. The method of claim 20, wherein the meloxicam and the rizatriptan are administered simultaneously, and wherein two hours after the meloxicam and the rizatriptan are administered, the human being experiences greater relief from vomiting than the human being would have experienced two hours after receiving the same amount of the meloxicam without the rizatriptan. 43. The method of claim 21, wherein the meloxicam and the rizatriptan are administered simultaneously, and wherein two hours after the meloxicam and the rizatriptan are administered, the human being experiences greater relief from vomiting than the human being would have experienced two hours after receiving the same amount of the rizatriptan without the meloxicam. 44. The method of claim 22, wherein the meloxicam and the rizatriptan are administered simultaneously, and wherein two hours after the meloxicam and the rizatriptan are administered, the human being experiences greater relief from photophobia than the human being would have experienced two hours after receiving the same amount of the meloxicam without the rizatriptan. 45. The method of claim 23, wherein the meloxicam and the rizatriptan are administered simultaneously, and wherein two hours after the meloxicam and the rizatriptan are administered, the human being experiences greater relief from photophobia than the human being would have experienced two hours after receiving the same amount of the rizatriptan without the meloxicam. 46. The method of claim 24, wherein the meloxicam and the rizatriptan are administered simultaneously, and wherein two hours after the meloxicam and the rizatriptan are administered, the human being experiences greater relief from phonophobia than the human being would have experienced two hours after receiving the same amount of the meloxicam without the rizatriptan. 47. The method of claim 25, wherein the meloxicam and the rizatriptan are administered simultaneously, and wherein two hours after the meloxicam and the rizatriptan are administered, the human being experiences greater relief from phonophobia than the human being would have experienced two hours after receiving the same amount of the rizatriptan without the meloxicam.