Claims for Patent: 11,806,354

Summary for Patent: 11,806,354

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:	US17/929,633
Patent Claims:	1. A method of treating migraine, comprising orally administering one tablet daily to a human being in need thereof, wherein the tablet comprises about 20 mg of meloxicam, or a molar equivalent amount of a salt form of meloxicam, and about 10 mg to about 15 mg of a rizatriptan in a salt form or the free base form, wherein the meloxicam is complexed with a sulfobutyl ether β-cyclodextrin (SBEβCD), wherein the Tmax of meloxicam in the human being is less than 60 minutes, wherein the human being has acute pain, wherein the human being experiences pain relief at about 2 hours after the tablet is orally administered, and wherein administration of the tablet achieves a reduction in pain that lasts at least about 24 hours. 2. The method of claim 1, wherein, upon orally administering the tablet, the Tmax of meloxicam in the human being is about 5×101 minutes. 3. The method of claim 1, wherein, upon orally administering the tablet, the Cmax of meloxicam in the human being is from about 2,500 ng/ml to about 3,000 ng/ml. 4. The method of claim 1, wherein, upon orally administering the tablet, the Cmax of meloxicam in the human being is about 3×103 ng/ml. 5. The method of claim 1, wherein, upon orally administering the tablet, the AUCo-inf of meloxicam in the human being is from about 50,000 ng*hr/ml to about 70,000 ng*hr/mL. 6. The method of claim 1, wherein, upon orally administering the tablet, the AUCo-inf of meloxicam in the human being is from about 50,000 ng*hr/mL to about 60,000 ng*hr/mL. 7. The method of claim 1, wherein, upon orally administering the tablet, the AUCo-inf of meloxicam in the human being is about 5×104 ng*hr/ml. 8. The method of claim 1, wherein, upon orally administering the tablet, the mean elimination half-life is approximately 20 hours for meloxicam. 9. A method of treating migraine, comprising orally administering one tablet daily to a human being in need thereof, wherein the tablet comprises about 20 mg of meloxicam, or a molar equivalent amount of a salt form of meloxicam, and about 10 mg to about 15 mg of a rizatriptan in a salt form or the free base form, wherein the meloxicam is complexed with a sulfobutyl ether β-cyclodextrin (SBEβCD), wherein the tablet further comprises sodium bicarbonate, wherein the Tmax of meloxicam in the human being is less than 60 minutes, wherein the human being has acute pain, wherein the human being experiences pain relief at about 2 hours after the tablet is orally administered, and wherein administration of the tablet achieves a reduction in pain that lasts at least about 24 hours. 10. The method of claim 9, wherein, upon orally administering the tablet, the Tmax of meloxicam in the human being is about 5×101 minutes. 11. The method of claim 9, wherein, upon orally administering the tablet, the Cmax of meloxicam in the human being is from about 2,500 ng/ml to about 3,000 ng/ml. 12. The method of claim 9, wherein, upon orally administering the tablet, the Cmax of meloxicam in the human being is about 3×103 ng/ml. 13. The method of claim 9, wherein, upon orally administering the tablet, the AUCo-inf of meloxicam in the human being is from about 50,000 ng*hr/ml to about 70,000 ng*hr/mL. 14. The method of claim 9, wherein, upon orally administering the tablet, the AUCo-inf of meloxicam in the human being is from about 50,000 ng*hr/ml to about 60,000 ng*hr/mL. 15. The method of claim 9, wherein, upon orally administering the tablet, the AUCo-inf of meloxicam in the human being is about 5×104 ng*hr/mL. 16. The method of claim 9, wherein, upon orally administering the tablet, the mean elimination half-life is approximately 20 hours for meloxicam.