Granted Patent B2

US 12,611,413 · App. 19/263,324 · Granted Apr 28, 2026

Inventor: Herriot Tabuteau (New York, NY)

Assignee: AXSOME THERAPEUTICS, INC.

A61K31/5415A61K31/4196A61P25/06

Abstract

Claims (26)

1 . A method of treating migraine in a human being in need thereof, comprising orally administering a tablet after the onset of a migraine attack to the human being, wherein the human being has at least 2 migraine attacks per month, wherein the tablet is administered intermittently for at least six months and up to 12 months to the human being, and wherein the tablet comprises about 20 mg of meloxicam, or a molar equivalent amount of a salt form of meloxicam, and about 10 mg of rizatriptan, or a molar equivalent amount of a salt form of rizatriptan.

2 . A method of treating migraine in a human being in need thereof, comprising orally administering a tablet after the onset of a migraine attack to the human being, wherein the human being is treated with the tablet at least 2 migraine attacks per month on average, wherein the human being is treated with the tablet for at least 12 months, and wherein the tablet comprises about 20 mg of meloxicam, or a molar equivalent amount of a salt form of meloxicam, and about 10 mg of rizatriptan, or a molar equivalent amount of a salt form of rizatriptan.

3 . A method of treating migraine in a human being in need thereof, comprising orally administering a tablet after the onset of a migraine attack to the human being, wherein the human being has at least 2 migraine attacks per month, wherein the tablet is administered intermittently for at least six months and up to 12 months to the human being, and wherein the tablet comprises 20 mg of meloxicam and 14.5 mg of rizatriptan benzoate.

4 . The method of claim 1 , wherein the tablet further comprises sodium bicarbonate, sulfobutyl-ether-β-cyclodextrin sodium, or a combination thereof.

5 . The method of claim 2 , wherein the tablet further comprises sodium bicarbonate, sulfobutyl-ether-β-cyclodextrin sodium, or a combination thereof.

6 . The method of claim 3 , wherein the tablet further comprises sodium bicarbonate, sulfobutyl-ether-β-cyclodextrin sodium, or a combination thereof.

7 . The method of claim 1 , wherein the tablet is administered to the human being for 12 months.

8 . The method of claim 1 , wherein, upon orally administering the tablet, the T max of meloxicam in the human being is less than 60 minutes.

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

10 . The method of claim 1 , wherein, upon orally administering the tablet, the T max of rizatriptan in the human being is less than 60 minutes.

11 . The method of claim 1 , wherein, upon orally administering the tablet, the median T max of rizatriptan in the human being is about 4×10 1 to about 5×10 1 minutes.

12 . 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.

13 . 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.

14 . The method of claim 1 , wherein, upon orally administering the tablet, the mean C max of meloxicam in the human being is 2,900 ng/mL.

15 . The method of claim 1 , wherein, upon orally administering the tablet, the mean AUC 0-24 of meloxicam in the human being is 33,000 ng*hr/mL.

16 . The method of claim 1 , wherein, upon orally administering the tablet, the mean C max of rizatriptan in the human being is about 30 ng/mL to about 40 ng/mL.

17 . The method of claim 1 , wherein, upon orally administering the tablet, the mean C max of rizatriptan in the human being is about 32 ng/mL.

18 . The method of claim 1 , wherein, upon orally administering the tablet, the mean AUC 0-24 of rizatriptan in the human being is about 80 ng*hr/mL to about 90 ng*hr/mL.

19 . The method of claim 1 , wherein, upon orally administering the tablet, the mean AUC 0-24 of rizatriptan in the human being is about 83 ng*hr/mL.

20 . The method of claim 1 , wherein, upon orally administering the tablet, the mean elimination half-life in the human being is about 2×10 1 hours for meloxicam.

21 . The method of claim 1 , wherein, upon orally administering the tablet, the mean elimination half-life in the human being is 18 hours for meloxicam.

22 . The method of claim 1 , wherein, upon orally administering the tablet, the mean elimination half-life in the human being is 2 hours for rizatriptan.

23 . The method of claim 1 , wherein the meloxicam is in the free acid form.

24 . The method of claim 1 , wherein the rizatriptan is rizatriptan benzoate.

25 . The method of claim 2 , wherein the meloxicam is in the free acid form.

26 . The method of claim 2 , wherein the rizatriptan is rizatriptan benzoate.

Assignments (1)

Continuity (6)

References Cited (363)