Claims for Patent: 12,472,258

Summary for Patent: 12,472,258

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:	US19/231,124
Patent Claims:	1. An oral dosage form comprising: meloxicam as a first therapeutically active agent, a bicarbonate, and a second therapeutically active agent, wherein the oral dosage form is a solid that is for direct oral administration, and has a median Tmax of meloxicam that is less than four hours in human beings when the solid dosage form is orally administered directly. 2. The oral dosage form of claim 1, wherein the second therapeutically active agent comprises aspirin. 3. The oral dosage form of claim 1, wherein the second therapeutically active agent comprises a second non-steroidal anti-inflammatory drug. 4. The oral dosage form of claim 1, wherein the second therapeutically active agent comprises at least one of an opioid, a steroid, and a triptan. 5. The oral dosage form of claim 1, wherein the median Tmax of meloxicam in the human being is less than 1 hour. 6. The oral dosage form of claim 1, wherein the median Tmax of meloxicam in the human being is between 10 minutes-180 minutes. 7. The oral dosage form of claim 1, wherein the oral solid dosage form achieves a reduction in pain that is observed at less than 30 minutes after being orally administered. 8. The oral dosage form of claim 1, wherein the oral solid dosage form achieves a reduction in pain that is observed at less than one hour after being orally administered. 9. The oral dosage form of claim 1, wherein the oral solid dosage form achieves a reduction in pain that lasts at least four hours after being orally administered. 10. The oral dosage form of claim 1, wherein the oral solid dosage form achieves a reduction in pain that lasts at least eight hours after being orally administered. 11. The oral dosage form of claim 1, wherein the oral solid dosage form achieves a reduction in pain that lasts at least twenty-four hours after being orally administered. 12. The oral dosage form of claim 1, wherein the oral solid dosage form comprises 1-50 mg meloxicam. 13. The oral dosage form of claim 1, wherein the oral solid dosage form comprises 1-15 mg meloxicam. 14. The oral dosage form of claim 1, wherein the oral dosage form is for the treatment of an acute pain. 15. The oral dosage form of claim 1, wherein the oral dosage form is for the treatment of a pain affecting a muscle. 16. The oral dosage form of claim 1, wherein the oral dosage form is for the treatment of a pain affecting a bone. 17. The oral dosage form of claim 1, wherein the oral dosage form is for the treatment of a pain affecting a ligament. 18. The oral dosage form of claim 1, wherein the oral dosage form is for the treatment of a pain affecting a tendon. 19. The oral dosage form of claim 1, wherein the oral solid dosage form comprises a cyclodextrin. 20. The oral dosage form of claim 1, wherein the first and second therapeutically active agents form an alternate solid form.