IP Library Granted Patent US 11,364,245
Granted Patent B2
US 11,364,245 · App. 17/398,368 · Granted Jun 21, 2022

Use of reboxetine to treat narcolepsy

Inventor: Herriot Tabuteau (New York, NY)
Assignee: AXSOME THERAPEUTICS, INC.
A61K31/5375A61P25/20
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Quick Facts
Patent No.
US 11,364,245
App. No.
17/398,368
Granted
Jun 21, 2022
Kind
B2
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 (16)

1. A method of rapidly reducing the number of cataplexy attacks in a human being having narcolepsy with cataplexy, comprising administering 8 mg to 10 mg of reboxetine daily for at least two weeks to the human being in need of treatment of reboxetine, wherein the human being has a minimum of 7 cataplexy attacks per week prior to receiving the reboxetine.

2. The method of claim 1 , wherein the reduction in the number of cataplexy attacks is statistically significant as compared to administering a placebo with p value that is less than 0.01.

3. The method of claim 1 , wherein 4 mg of the reboxetine is administered twice a day to the human being for a first week.

4. The method of claim 3 , wherein 4 mg of the reboxetine is administered to the human being in the morning and 4 mg of the reboxetine is administered to the human being in the afternoon for a second week.

5. The method of claim 1 , wherein 6 mg of the reboxetine is administered to the human being in the morning and 4 mg of the reboxetine is administered to the human being in the afternoon for a first week.

6. The method of claim 1 , wherein the human being has a diagnosis of narcolepsy with cataplexy that meets International Classification of Sleep Disorders, Third Edition criteria.

7. The method of claim 1 , wherein the human being has an Epworth Sleepiness Scale score that is greater than 10 prior to receiving the reboxetine.

8. The method of claim 5 , wherein 6 mg of the reboxetine is administered to the human being in the morning and 4 mg of the reboxetine is administered to the human being in the afternoon for a second week.

9. The method of claim 1 , wherein 5 mg of the reboxetine is administered to the human being in the morning and 5 mg of the reboxetine is administered to the human being in the afternoon for a first week.

10. The method of claim 9 , wherein 5 mg of the reboxetine is administered to the human being in the morning and 5 mg of the reboxetine is administered to the human being in the afternoon for a second week.

11. The method of claim 1 , wherein one week after the start of the treatment, the human being has at least 30% fewer cataplexy attacks as compared to baseline.

12. The method of claim 1 , wherein two weeks after the start of the treatment, the human being has at least 40% fewer cataplexy attacks as compared to baseline.

13. The method of claim 1 , wherein one week after the start of the treatment, the human being is more likely to achieve a 50% or greater reduction in the weekly number of cataplexy attacks as compared with taking a placebo for one week.

14. The method of claim 1 , wherein two weeks after the start of the treatment, the human being is more likely to achieve a 50% or greater reduction in the weekly number of cataplexy attacks as compared with taking a placebo for 2 weeks.

15. The method of claim 1 , wherein one week after the start of the treatment, the human being is more likely to achieve a 75% or greater reduction in the weekly number of cataplexy attacks as compared with taking a placebo for one week.

16. The method of claim 1 , wherein two weeks after the start of the treatment, the human being is more likely to achieve a 50% or greater reduction in the weekly number of cataplexy attacks as compared with taking a placebo for 2 weeks.

Assignments (2)
SECURITY INTEREST Recorded May 9, 2025
From: AXSOME THERAPEUTICS, INC.; AXSOME MALTA LTD.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 071247/0836 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 7, 2021
From: TABUTEAU, HERRIOT
To: AXSOME THERAPEUTICS, INC.
Reel/Frame 058039/0103 →
Cited By (2)
US 12,565,478 US 12,616,702