IP Library Patent Application 19278727
Patent Application
App. No. 19/278,727

USE OF ESREBOXETINE TO TREAT NERVOUS SYSTEM DISORDERS SUCH AS FIBROMYALGIA

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Patent No.
US None
App. No.
19/278,727
Abstract

Described herein are methods of treating narcolepsy with cataplexy, comprising administering reboxetine (including esreboxetine) to a human being in need thereof. Reboxetine (including esreboxetine) may also be used in the manufacture of a medicament for the treatment of narcolepsy with cataplexy. Also disclosed herein are kits comprising a pharmaceutical composition comprising reboxetine (including esreboxetine) and instructions to use the pharmaceutical composition to treat narcolepsy with cataplexy in a human being.

Claims (17)

1 . A method of treating fibromyalgia, comprising administering esreboxetine to a human being in need thereof, wherein a daily dose of about 1 mg to about 2 mg of esreboxetine is administered for at least six weeks, wherein the human being experiences a reduction in fibromyalgia pain during the course of the treatment, as measured by a visual analog scale (VAS) score, that is greater than the reduction in pain that the human being would have experienced by administering a placebo.

2 . The method of claim 1 , wherein about 1 mg to about 2 mg of esreboxetine is administered once a day.

3 . The method of claim 1 , wherein about 0.5 mg to about 1 mg of esreboxetine is administered twice a day.

4 . The method of claim 1 , wherein the human being is selected for having a Global Fatigue Index score of at least about 8.

5 . The method of claim 1 , wherein after esreboxetine is administered daily for six weeks, the VAS score of the fibromyalgia pain of the human being is reduced by at least 20% as compared to the VAS score of the fibromyalgia pain of the human being immediately prior to administering the first dose of esreboxetine.

6 . The method of claim 1 , wherein after esreboxetine is administered daily for six weeks, the VAS score of the fibromyalgia pain of the human being is reduced by at least 50% as compared to the VAS score of the fibromyalgia pain of the human being immediately prior to administering the first dose of esreboxetine.

7 . A method of treating fibromyalgia, comprising administering esreboxetine to a human being in need thereof, wherein a daily dose of about 2 mg to about 4 mg of esreboxetine is administered for at least six weeks, wherein the human being experiences a reduction in pain during the course of the treatment, as measured by a visual analog scale (VAS) score, that is greater than the reduction in pain that the human being would have experienced by administering a placebo.

8 . The method of claim 7 , wherein about 2 mg to about 4 mg of esreboxetine is administered once a day.

9 . The method of claim 7 , wherein about 1 mg to about 2 mg of esreboxetine is administered twice a day.

10 . The method of claim 7 , wherein the human being is selected for having a Global Fatigue Index score of at least about 8.

11 . The method of claim 7 , wherein after esreboxetine is administered daily for six weeks, the VAS score of the fibromyalgia pain of the human being is reduced by at least 20% as compared to the VAS score of the fibromyalgia pain of the human being immediately prior to administering the first dose of esreboxetine.

12 . The method of claim 7 , wherein after esreboxetine is administered daily for six weeks, the VAS score of the fibromyalgia pain of the human being is reduced by at least 50% as compared to the VAS score of the fibromyalgia pain of the human being immediately prior to administering the first dose of esreboxetine.

13 . A method of treating fibromyalgia, comprising administering esreboxetine to a human being in need thereof, wherein a daily dose of about 0.5 mg to about 1 mg of esreboxetine is administered for at least six weeks, wherein the human being experiences a reduction in fibromyalgia pain during the course of the treatment, as measured by a visual analog scale (VAS) score, that is greater than the reduction in pain that the human being would have experienced by administering a placebo.

14 . The method of claim 13 , wherein about 0.5 mg to about 1 mg of esreboxetine is administered once a day.

15 . The method of claim 13 , wherein the human being is selected for having a Global Fatigue Index score of at least about 8.

16 . The method of claim 13 , wherein after esreboxetine is administered daily for six weeks, the VAS score of the fibromyalgia pain of the human being is reduced by at least 20% as compared to the VAS score of the fibromyalgia pain of the human being immediately prior to administering the first dose of esreboxetine.

17 . The method of claim 13 , wherein after esreboxetine is administered daily for six weeks, the VAS score of the fibromyalgia pain of the human being is reduced by at least 50% as compared to the VAS score of the fibromyalgia pain of the human being immediately prior to administering the first dose of esreboxetine.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 21, 2025
From: TABUTEAU, HERRIOT
To: AXSOME THERAPEUTICS, INC.
Reel/Frame 072360/0140 →