IP Library › Granted Patent US 12,447,155
Granted Patent B2
US 12,447,155 · App. 19/024,709 · Granted Oct 21, 2025

Use of reboxetine to treat narcolepsy

Inventor: Herriot Tabuteau (New York, NY)
Assignee: Axsome Therapeutics, Inc.
A61K31/5375A61P25/02A61P25/20
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Quick Facts
Patent No.
US 12,447,155
App. No.
19/024,709
Granted
Oct 21, 2025
Kind
B2
Abstract

Described herein are methods of treating narcolepsy with cataplexy, comprising administering reboxetine to a human being in need thereof. Reboxetine 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 and instructions to use the pharmaceutical composition to treat narcolepsy with cataplexy in a human being.

Claims (16)

1. A method of treating narcolepsy with cataplexy, comprising administering a dosage form once daily for one week, and then twice daily for at least one week, to a human patient in need thereof, wherein the dosage form comprises 5 mg of reboxetine free base, or a molar equivalent amount of a salt form of reboxetine, and microcrystalline cellulose, wherein the human patient has a minimum of 7 cataplexy attacks per week prior to receiving reboxetine.

2. 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.

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

4. The method of claim 1 , wherein the human patient has a diagnosis of narcolepsy with cataplexy that meets International Classification of Sleep Disorders, Third Edition criteria, and does not have a concomitant sleep disorder.

5. A method of treating narcolepsy with cataplexy, comprising administering a dosage form once daily for one week, and then twice daily for at least one week, to a human patient in need thereof, wherein the dosage form comprises 5 mg of reboxetine free base, or a molar equivalent amount of a salt form of reboxetine, and hydroxypropyl methylcellulose, wherein the human patient has a minimum of 7 cataplexy attacks per week prior to receiving reboxetine.

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 reboxetine.

8. The method of claim 1 , wherein the human patient has a diagnosis of narcolepsy with cataplexy that meets International Classification of Sleep Disorders, Third Edition criteria, and does not have a concomitant sleep disorder.

9. A method of treating narcolepsy with cataplexy, comprising administering a dosage form once daily for one week, and then twice daily for at least one week, to a human patient in need thereof, wherein the dosage form comprises 5 mg of reboxetine free base, or a molar equivalent amount of a salt form of reboxetine, and polyvinylpyrrolidone, wherein the human patient has a minimum of 7 cataplexy attacks per week prior to receiving reboxetine.

10. 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.

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

12. The method of claim 1 , wherein the human patient has a diagnosis of narcolepsy with cataplexy that meets International Classification of Sleep Disorders, Third Edition criteria, and does not have a concomitant sleep disorder.

13. A method of treating narcolepsy with cataplexy, comprising administering a dosage form once daily for one week, and then twice daily for at least one week, to a human patient in need thereof, wherein the dosage form comprises 5 mg of reboxetine free base, or a molar equivalent amount of a salt form of reboxetine, and colloidal silica, wherein the human patient has a minimum of 7 cataplexy attacks per week prior to receiving reboxetine.

14. 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.

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

16. The method of claim 1 , wherein the human patient has a diagnosis of narcolepsy with cataplexy that meets International Classification of Sleep Disorders, Third Edition criteria, and does not have a concomitant sleep disorder.

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 18, 2025
From: TABUTEAU, HERRIOT
To: AXSOME THERAPEUTICS, INC.
Reel/Frame 070250/0077 →
Continuity (8)
Continuation 18389771 · Dec 19, 2023
Continuation 17751490 · May 23, 2022
Continuation 16740409 · Jan 11, 2020
Continuation In Part PCTUS2019056134 · Oct 14, 2019
Provisional Application 62946295 · Dec 10, 2019
Provisional Application 62943077 · Dec 3, 2019
Provisional Application 62745956 · Oct 15, 2018
Related Publication 20250161316A1 · May 22, 2025
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