IP Library › Granted Patent US 12,521,377
Granted Patent B2
US 12,521,377 · App. 15/939,831 · Granted Jan 13, 2026

Uses of (+)-B-dihydrotetrabenazine in methods of treating movement disorder

Inventors: Andrew John Duffield (Berkhamsted, GB); Anant Pandya (Croydon, GB)
Assignee: ADEPTIO PHARMACEUTICALS LIMITED
A61K31/435A61P25/14A61K9/20A61K9/2004A61K9/48
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Quick Facts
Patent No.
US 12,521,377
App. No.
15/939,831
Granted
Jan 13, 2026
Kind
B2
Abstract

This invention relates to pharmaceutical compositions containing (+)-β-dihydrotetrabenazine and their therapeutic uses, in particular in their use in the treatment of movement disorders, such as Tourette's syndrome.

Claims (20)

1 . A method of treating a hyperkinetic movement disorder in a subject in need thereof, the method comprising administering to the subject 5 mg to 100 mg per day of (+)-β-dihydrotetrabenazine, or a pharmaceutically acceptable salt thereof, in an immediate release pharmaceutical composition comprising the (+)-β-dihydrotetrabenazine, or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable excipient, wherein the (+)-β-dihydrotetrabenazine is accompanied by no more than 20% by weight, relative to the (+)-β-dihydrotetrabenazine, of any other dihydrotetrabenazine isomers, and wherein the (+)-β-dihydrotetrabenazine or the pharmaceutically acceptable salt thereof is not administered with an effective amount of amantadine.

2 . A method according to claim 1 wherein the hyperkinetic movement disorder is selected from Huntington's disease, hemiballismus, senile chorea, tic disorders, tardive dyskinesia, dystonia and Tourette's syndrome.

3 . A method according to claim 1 wherein the method comprises administering approximately 10 mg of (+)-β-dihydrotetrabenazine.

4 . A method according to claim 1 wherein the method comprises administering approximately 20 mg of (+)-β-dihydrotetrabenazine.

5 . A method according to claim 1 wherein the method comprises administering approximately 30 mg of (+)-β-dihydrotetrabenazine.

6 . A method according to claim 1 wherein the method comprises administering approximately 40 mg of (+)-β-dihydrotetrabenazine.

7 . A method according to claim 1 wherein the method comprises administering approximately 50 mg of (+)-β-dihydrotetrabenazine.

8 . A method according to claim 1 wherein the method comprises administering approximately 60 mg of (+)-β-dihydrotetrabenazine.

9 . A method of treating a hyperkinetic movement disorder in a subject in need thereof, the method comprising administering to the subject 5 mg to 100 mg per day of (+)-β-dihydrotetrabenazine or a pharmaceutically acceptable salt thereof, wherein the (+)-β-dihydrotetrabenazine or the pharmaceutically acceptable salt thereof is not administered with an effective amount of amantadine and wherein the (+)-β-dihydrotetrabenazine or the pharmaceutically acceptable salt is administered as an immediate release unit dosage form.

10 . A method according to claim 9 wherein the hyperkinetic movement disorder is selected from Huntington's disease, hemiballismus, senile chorea, tic disorders, tardive dyskinesia, dystonia and Tourette's syndrome.

11 . A method according to claim 9 wherein the method comprises administering to a subject an amount of (+)-β-dihydrotetrabenazine from 0.01 mg/kg to 2.0 mg/kg per day, provided that the total amount of (+)-β-dihydrotetrabenazine administered per day is in the range from 5 mg to 100 mg.

12 . A method according to claim 9 wherein the method comprises administering to a subject an amount of (+)-β-dihydrotetrabenazine sufficient to cause a level of blocking of from 20% to 90% of the VMAT2 proteins in the subject.

13 . A method according to claim 9 wherein the (+)-β-dihydrotetrabenazine has an isomeric purity of at least 80%.

14 . A method according to claim 9 wherein (+)-β-dihydrotetrabenazine or the pharmaceutically acceptable salt thereof is not administered with amantadine in any amount.

15 . A method according to claim 9 wherein the method comprises administering approximately 20 mg of (+)-β-dihydrotetrabenazine.

16 . A method according to claim 9 wherein the method comprises administering approximately 30 mg of (+)-β-dihydrotetrabenazine.

17 . A method according to claim 9 wherein the method comprises administering approximately 40 mg of (+)-β-dihydrotetrabenazine.

18 . A method according to claim 9 wherein the method comprises administering approximately 50 mg of (+)-β-dihydrotetrabenazine.

19 . A method according to claim 9 wherein the method comprises administering approximately 60 mg of (+)-β-dihydrotetrabenazine.

20 . A method according to claim 9 wherein the method comprises administering approximately 40 mg to 100 mg of (+)-β-dihydrotetrabenazine.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 23, 2020
From: DUFFIELD, ANDREW JOHN; PANDYA, ANANT
To: ADEPTIO PHARMACEUTICALS LIMITED
Reel/Frame 052195/0497 →
Priority Claims (1)
GB 1705305 · Apr 1, 2017 · national
Continuity (2)
Provisional Application 62515935 · Jun 6, 2017
Related Publication 20180280360A1 · Oct 4, 2018
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