IP Library Granted Patent US 11,351,175
Granted Patent B2
US 11,351,175 · App. 16/740,409 · Granted Jun 7, 2022

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 11,351,175
App. No.
16/740,409
Granted
Jun 7, 2022
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 (24)

1. A method of improving the ability to concentrate 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 thereof, wherein the human being has a minimum of 7 cataplexy attacks per week prior to receiving reboxetine, wherein, prior to the start of treatment, the human being has an ability to concentrate that is “average,” “poor,” or “very poor,” and two weeks after the start of the treatment, the human being has an ability to concentrate that is “good” or “very good,” as determined by the Ability to Concentrate Item of the Narcolepsy Symptom Assessment Questionnaire.

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

4. The method of claim 1 , 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 at least one 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 an Epworth Sleepiness Scale score that is greater than 10 prior to receiving reboxetine.

7. A method of reducing the number of inadvertent naps 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 thereof, wherein the human being has a minimum of 7 cataplexy attacks per week prior to receiving reboxetine, wherein two weeks after the start of the treatment, the human being has at least 20% fewer inadvertent naps per week as compared to the week before the patient first receives reboxetine.

8. The method of claim 7 , wherein about 4 mg of reboxetine is administered twice a day to the human being for at least one week.

9. The method of claim 8 , 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 at least one week.

10. The method of claim 7 , 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 at least one week.

11. The method of claim 7 , wherein the human being has a diagnosis of narcolepsy with cataplexy that meets International Classification of Sleep Disorders, Third Edition criteria.

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

13. A method of improving sleep quality 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 thereof, wherein the human being has a minimum of 7 cataplexy attacks per week prior to receiving reboxetine, wherein two weeks after the start of the treatment, the human being reports having improved sleep quality as compared to the week before the patient first receives reboxetine.

14. The method of claim 13 , wherein about 4 mg of reboxetine is administered twice a day to the human being for at least one week.

15. The method of claim 14 , 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 at least one week.

16. The method of claim 13 , 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 at least one week.

17. The method of claim 13 , wherein the human being has a diagnosis of narcolepsy with cataplexy that meets International Classification of Sleep Disorders, Third Edition criteria.

18. The method of claim 13 , wherein the human being has an Epworth Sleepiness Scale score that is greater than 10 prior to receiving reboxetine.

19. 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 thereof, wherein the human being has a minimum of 7 cataplexy attacks per week prior to receiving 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 patient first receives reboxetine.

20. The method of claim 19 , wherein about 4 mg of reboxetine is administered twice a day to the human being for at least one week.

21. The method of claim 20 , 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 at least one week.

22. The method of claim 19 , 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 at least one week.

23. The method of claim 19 , wherein the human being has a diagnosis of narcolepsy with cataplexy that meets International Classification of Sleep Disorders, Third Edition criteria.

24. The method of claim 19 , wherein the human being has an Epworth Sleepiness Scale score that is greater than 10 prior to receiving reboxetine.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded May 22, 2025
From: HERCULES CAPITAL, INC.
To: AXSOME THERAPEUTICS, INC.
Reel/Frame 071337/0004 →
SECURITY INTEREST Recorded May 9, 2025
From: AXSOME THERAPEUTICS, INC.; AXSOME MALTA LTD.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 071247/0836 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Sep 25, 2020
From: AXSOME THERAPEUTICS, INC.
To: HERCULES CAPITAL, INC., AS AGENT
Reel/Frame 053941/0491 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 12, 2020
From: TABUTEAU, HERRIOT
To: AXSOME THERAPEUTICS, INC.
Reel/Frame 052102/0337 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 11, 2020
From: TABUTEAU, HERRIOT
To: AXSOME THERAPEUTICS, INC.
Reel/Frame 052089/0385 →