IP Library Granted Patent US 12,616,702
Granted Patent B2
US 12,616,702 · App. 18/820,232 · Granted May 5, 2026

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 12,616,702
App. No.
18/820,232
Granted
May 5, 2026
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 (17)

1 . A method of reducing the number of inadvertent naps in a human being having narcolepsy with cataplexy, comprising administering from 5 mg to 10 mg of reboxetine, or a molar equivalent amount of a pharmaceutically acceptable salt thereof, daily for at least two weeks to a human being in need thereof, wherein the human being is experiencing narcolepsy with cataplexy, wherein the human being is selected for having experienced at least 7 cataplexy attacks in the week before the human being first received reboxetine, wherein during the second week that reboxetine is administered, the human being experiences at least 20% fewer inadvertent naps per week as compared to the week before the human being first received reboxetine.

2 . The method of claim 1 , wherein 5 mg of reboxetine, or a molar equivalent amount of a pharmaceutically acceptable salt thereof, is administered once a day.

3 . The method of claim 1 , wherein reboxetine, or a pharmaceutically acceptable salt thereof, is administered in a dosage form further containing a polymer.

4 . The method of claim 1 , wherein reboxetine, or a pharmaceutically acceptable salt thereof, is administered in a dosage form further containing a binder.

5 . The method of claim 1 , wherein reboxetine, or a pharmaceutically acceptable salt thereof, is administered in a dosage form further containing a lubricant.

6 . The method of claim 1 , wherein reboxetine, or a pharmaceutically acceptable salt thereof, is administered in a dosage form further containing a diluent.

7 . The method of claim 1 , wherein reboxetine, or a pharmaceutically acceptable salt thereof, is administered in a dosage form further containing a disintegrant.

8 . The method of claim 1 , wherein 5 mg of the reboxetine, or a molar equivalent amount of a pharmaceutically acceptable salt thereof, is administered twice a day to the human being for a first week.

9 . The method of claim 8 , wherein 5 mg of the reboxetine, or a molar equivalent amount of a pharmaceutically acceptable salt thereof, is administered to the human being in the morning and 5 mg of the reboxetine, or a molar equivalent amount of a pharmaceutically acceptable salt thereof, is administered to the human being in the afternoon.

10 . The method of claim 1 , wherein 6 mg to 7 mg of a pharmaceutically acceptable salt of reboxetine is administered to the human being in the morning and 6 mg to 7 mg of a pharmaceutically acceptable salt of reboxetine is administered to the human being in the afternoon.

11 . The method of claim 1 , wherein 6 mg to 7 mg of the pharmaceutically acceptable salt of reboxetine is administered to the human being in the morning.

12 . The method of claim 2 , wherein the 5 mg of the reboxetine, or a molar equivalent amount of a pharmaceutically acceptable salt thereof, is administered to the human being once daily for a first week.

13 . The method of claim 1 , wherein 5 mg of the reboxetine, or a molar equivalent amount of a pharmaceutically acceptable salt thereof, is administered to the human being once daily for a first week, and

wherein 5 mg of the reboxetine, or a molar equivalent amount of a pharmaceutically acceptable salt thereof, is administered to the human being in the morning and 5 mg of the reboxetine, or a molar equivalent amount of a pharmaceutically acceptable salt thereof, is administered to the human being in the afternoon for a second week.

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 the reboxetine.

16 . The method of claim 1 , wherein the reboxetine is in a pharmaceutically acceptable salt form.

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 12, 2024
From: TABUTEAU, HERRIOT
To: AXSOME THERAPEUTICS, INC.
Reel/Frame 069239/0830 →