Use of riluzole prodrugs to treat alzheimer's disease

Patent metadata

Field	Value
Publication number	US-12161633-B2
Application number	US-201917261057-A
Country	US
Kind code	B2
Filing date	Jul 20, 2019
Priority date	Jul 22, 2018
Publication date	Dec 10, 2024
Grant date	Dec 10, 2024

Abstract

Disclosed are methods of treating Alzheimer's Disease by administering to a patient in need thereof a riluzole prodrug such as troriluzole. Pharmaceutical compositions and kits including the riluzole prodrugs are also disclosed.

First claim

What is claimed is:

1. A method of treating Alzheimer's Disease in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of a riluzole prodrug, wherein the riluzole prodrug has the following formula:

or a pharmaceutically acceptable salt thereof, and
wherein the riluzole prodrug is adminstered to the patient at a dosage of from about 100 to 400 mg per day.

2. The method of claim 1 , wherein the riluzole prodrug is administered to the patient at a dosage of about 110, or 140, or 150, or 210, or 280, or 350 mg per day.

3. The method of claim 2 , wherein the riluzole prodrug is administered to the patient at a dosage of 280 mg, once per day.

4. The method of claim 3 , wherein the riluzole prodrug is administered to the patient at a dosage of 140 mg, twice per day.

5. The method of claim 1 , wherein the riluzole prodrug is administered to the patient once per day.

6. The method of claim 1 , wherein the riluzole prodrug is administered to the patient twice per day.

7. The method of claim 1 , wherein the riluzole prodrug is administered to the patient in the form of a capsule.

8. The method of claim 1 , wherein the riluzole prodrug is administered to the patient in the form of a tablet.

9. The method of claim 1 , wherein the riluzole prodrug is administered to the patient for a duration of from about 8 weeks to 48 weeks.

10. The method of claim 1 , wherein the riluzole prodrug is administered to the patient for a duration of from the onset of treatment to the end of the patient's life.

11. A method for improving a response in a patient afflicted with Alzheimer's disease comprising administering to the patient in need thereof, an effective amount of a riluzole prodrug,
wherein the riluzole prodrug has the following formula:

or a pharmaceutically acceptable salt thereof, and
wherein the riluzole prodrug is administered to the patient at a dosage of from about 100 to 400 mg per day.

12. The method of claim 11 , wherein the improved response is one or more of overall survival, quality of life, overall response rate, duration of response, delay of onset, or patient reported outcome.

13. A kit for treating a patient afflicted with Alzheimer's Disease, the kit comprising:
(a) a riluzole prodrug; and
(b) instructions for administering the riluzole prodrug in the method of claim 1 ,
wherein the riluzole prodrug has the following formula:

or a pharmaceutically acceptable salt thereof, and
wherein the riluzole prodrug is administered to the patient at a dosage of from about 100 to 400 mg per day.

Assignees

• Biohaven Therapeutics Ltd

Inventors

• Coric Vladimir
• Berman Robert
• Qureshi Irfan

Classifications

• A61K9/48

  Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)} · CPC title

• A61P25/28

  for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia · CPC title

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• C07D277/82

  Nitrogen atoms · CPC title

• A61K31/428 Primary

  condensed with carbocyclic rings · CPC title