IP Library Granted Patent US 11,020,402
Granted Patent B2
US 11,020,402 · App. 17/119,792 · Granted Jun 1, 2021

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 11,020,402
App. No.
17/119,792
Granted
Jun 1, 2021
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 (11)

1. A method of reducing night awakenings in a human being having narcolepsy with cataplexy, comprising administering about 8 mg to about 10 mg of reboxetine daily for at least two weeks to a human being in need of treatment with reboxetine, wherein two weeks after the start of the treatment, the human being reports having fewer night awakenings as compared to the week before the human being first receives reboxetine.

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

3. The method of claim 2 , wherein about 4 mg of reboxetine is administered to the human being in the morning and about 4 mg of reboxetine is administered to the human being in the afternoon for a second week.

4. The method of claim 2 , wherein about 6 mg of reboxetine is administered to the human being in the morning and about 4 mg of reboxetine is administered to the human being in the afternoon for a second week.

5. 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.

6. The method of claim 1 , wherein the human being has a minimum of 7 cataplexy attacks per week prior to receiving reboxetine.

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

8. The method of claim 1 , wherein the human being is selected for being in need of reducing night awakenings.

9. The method of claim 1 , wherein the human being is selected for having a minimum of 7 cataplexy attacks per week prior to receiving reboxetine.

10. The method of claim 1 , wherein the human being has at least a 20% reduction in the number of night awakenings after the administration of reboxetine as compared to baseline.

11. The method of claim 1 , wherein, after the administration of reboxetine, the human being has fewer night awakenings than would have occurred if the human being had been administered a placebo.

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 Feb 22, 2021
From: TABUTEAU, HERRIOT
To: AXSOME THERAPEUTICS, INC.
Reel/Frame 055361/0343 →