Granted Patent B2

US 12,551,489 · App. 19/222,910 · Granted Feb 17, 2026

Inventor: Herriot Tabuteau (New York, NY)

Assignee: AXSOME THERAPEUTICS, INC.

A61K31/5415A61K31/192A61K31/4196A61K33/00A61K47/02A61K47/40A61K47/6951A61P25/06

Abstract

Claims (23)

1 . A method of treating migraine, comprising orally administering one tablet to a human being experiencing a migraine attack, wherein the human being has 2 to 3 migraine attacks per month, wherein the tablet comprises about 20 mg of meloxicam, or a molar equivalent amount of a salt form of meloxicam, and from about 10 mg to about 15 mg of rizatriptan, or a molar equivalent amount of a salt form of rizatriptan, wherein the meloxicam is complexed with a sulfobutyl ether β-cyclodextrin (SBEBCD), wherein the human being does not have a cluster headache, wherein the T max of meloxicam in the human being is less than 60 minutes, and wherein the human being has acute pain.

2 . The method of claim 1 , wherein, upon orally administering the tablet, the T max of meloxicam in the human being is about 5×10 1 minutes.

3 . The method of claim 1 , wherein, upon orally administering the tablet, the C max 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 C max of meloxicam in the human being is about 3×10 3 ng/ml.

5 . The method of claim 1 , wherein, upon orally administering the tablet, the AUC 0-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 AUC 0-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 AUC 0-inf of meloxicam in the human being is about 5×10 4 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 to a human being experiencing a migraine attack, wherein the human being has 2 to 3 migraine attacks per month, wherein the tablet comprises about 20 mg of meloxicam, or a molar equivalent amount of a salt form of meloxicam, and from about 10 mg to about 15 mg of rizatriptan, or a molar equivalent amount of a salt form of rizatriptan, wherein the tablet further comprises sodium bicarbonate, wherein the human being does not have a cluster headache, wherein the T max of meloxicam in the human being is less than 60 minutes, and wherein the human being has acute pain.

10 . The method of claim 9 , wherein, upon orally administering the tablet, the T max of meloxicam in the human being is about 5×10 1 minutes.

11 . The method of claim 9 , wherein, upon orally administering the tablet, the C max 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 C max of meloxicam in the human being is about 3×10 3 ng/ml.

13 . The method of claim 9 , wherein, upon orally administering the tablet, the AUC 0-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 AUC 0-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 AUC 0-inf of meloxicam in the human being is about 5×10 4 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.

17 . The method of claim 1 , wherein the human being experiences pain relief at about 2 hours after the tablet is orally administered.

18 . The method of claim 9 , wherein the human being experiences pain relief at about 2 hours after the tablet is orally administered.

19 . A method of treating migraine, comprising orally administering one tablet to a human being experiencing a migraine attack, wherein the human being has 2 to 3 migraine attacks per month, wherein the tablet comprises 20 mg of meloxicam and 14.5 mg of rizatriptan benzoate, wherein the human being does not have a cluster headache, wherein the T max of meloxicam in the human being is less than 60 minutes, and wherein the human being has acute pain.

20 . A method of treating migraine, comprising orally administering one tablet to a human being experiencing a migraine attack, wherein the human being has 2 to 3 migraine attacks per month, wherein the tablet comprises 20 mg of meloxicam and 14.5 mg of rizatriptan benzoate, wherein the tablet further comprises sodium bicarbonate, wherein the human being does not have a cluster headache, wherein the T max of meloxicam in the human being is less than 60 minutes, and wherein the human being has acute pain.

21 . The method of claim 1 , wherein the tablet further comprises a sulfobutyl ether β-cyclodextrin.

22 . The method of claim 9 , wherein the tablet further comprises a sulfobutyl ether β-cyclodextrin.

23 . The method of claim 20 , wherein the tablet further comprises a sulfobutyl ether β-cyclodextrin.

Assignments (1)

Continuity (7)

References Cited (364)