IP Library Granted Patent US 11,135,226
Granted Patent B2
US 11,135,226 · App. 17/177,554 · Granted Oct 5, 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 11,135,226
App. No.
17/177,554
Granted
Oct 5, 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 (13)

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

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

3. The method of claim 2 , 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.

4. The method of claim 1 , wherein about 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 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 the 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 the reboxetine.

8. The method of claim 1 , wherein the human being has at least a 40% reduction in sleep paralysis episodes after the administration of the reboxetine.

9. The method of claim 1 , wherein after the administration of the reboxetine, the human being has fewer sleep paralysis episodes than would have occurred if the human being had been administered a placebo.

10. The method of claim 1 , wherein the human being is selected for being in need of reducing sleep paralysis.

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

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

13. The method of claim 1 , wherein, after the administration of the reboxetine, the human being has fewer sleep paralysis 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 May 17, 2021
From: TABUTEAU, HERRIOT
To: AXSOME THERAPEUTICS, INC.
Reel/Frame 056259/0713 →
Continuity (10)
Division 17119792 · Dec 11, 2020
Continuation In Part PCTUS2020062560 · Nov 30, 2020
Continuation In Part 16740329 · Jan 10, 2020
Continuation In Part 16740409 · Jan 11, 2020
Continuation In Part 16740410 · Jan 11, 2020
Continuation In Part PCTUS2019056134 · Oct 14, 2019
Provisional Application 62943077 · Dec 3, 2019
Provisional Application 62946295 · Dec 10, 2019
Provisional Application 62745956 · Oct 15, 2018
Related Publication 20210169893A1 · Jun 10, 2021
Cited By (4)
US 12,246,023 US 12,447,155 US 12,565,478 US 12,616,702