Pharmaceutical compositions for combination therapy
This invention relates to novel pharmaceutical compositions comprising a therapeutically effective combination of a dopaminergic stabilizer known as Pridopidine, and an inhibitor of the vesicular monoamine transporter type 2 (VMAT) known as Tetrabenazine. The pharmaceutical compositions for use according to the invention are contemplated particularly useful for improving the symptomatic therapeutic effects, and for reducing the adverse effects, of Tetrabenazine in the treatment of movement disorders, and in articular movement disorders associated with Huntington's disease, Gilles de la Tourette's syndrome, or tardive dyskinesia.
1. A method of treating a subject afflicted with a movement disorder comprising administering to the subject an amount of Tetrabenazine or a pharmaceutically acceptable salt thereof, and an amount of Pridopidine or a pharmaceutically acceptable salt thereof; wherein the method reduces depression induced by Tetrabenazine and/or improves functional capacity decline induced by Tetrabenazine and/or improves motor deficits induced by Tetrabenazine.
2. The method of claim 1 , wherein the amounts when taken together are more effective to treat the subject than when each agent at the same amount is administered alone.
3. A method of reducing or preventing one or more side effects of periodic administration of an amount of Tetrabenazine or a pharmaceutically acceptable salt thereof to a subject, comprising periodically administering to the subject an amount of Pridopidine or a pharmaceutically acceptable salt thereof.
4. The method of claim 3 , wherein the one or more side effects are selected from depression, suicidality, akathisia, restlessness, agitation, parkinsonism, sedation, somnolence, and dysphagia.
5. The method of claim 3 , wherein the subject is afflicted with a movement disorder.
6. The method of claim 1 , wherein the amount of Tetrabenazine or a pharmaceutically acceptable salt thereof is administered via oral administration.
7. The method of claim 1 , wherein the amount of Tetrabenazine or a pharmaceutically acceptable salt thereof is administered daily, twice daily or three times daily.
8. The method of claim 1 , wherein the amount of Tetrabenazine or a pharmaceutically acceptable salt thereof is 0.05 mg/kg per day to 0.20 mg/kg per day.
9. The method of claim 1 , wherein the amount of Tetrabenazine or a pharmaceutically acceptable salt thereof is 1-500 mg/day.
10. The method of claim 1 , wherein the amount of Pridopidine or a pharmaceutically acceptable salt thereof is administered via oral administration.
11. The method of claim 1 , wherein the amount of Pridopidine or a pharmaceutically acceptable salt thereof is administered daily or twice daily.
12. The method of claim 1 , wherein the amount of Pridopidine or a pharmaceutically acceptable salt thereof is 1.5 μmol/kg per day to 20 μmol/kg per day.
13. The method of claim 1 , wherein the amount of Pridopidine or a pharmaceutically acceptable salt thereof is 1-500 mg/day.
14. The method of claim 1 , wherein the movement disorder is Huntington's disease, Tourette's syndrome, or tardive dyskinesia.
15. The method of claim 1 , wherein the amount of Tetrabenazine or a pharmaceutically acceptable salt thereof and the amount of Pridopidine or a pharmaceutically acceptable salt thereof is effective to alleviate a symptom of the movement disorder.
16. The method of claim 15 , wherein the symptom is chorea.
17. The method of claim 1 , wherein the subject is receiving Tetrabenazine therapy prior to initiating administration of Pridopidine or a pharmaceutically acceptable salt thereof.
18. The method of claim 1 , wherein the amount of Tetrabenazine or a pharmaceutically acceptable salt thereof and the amount of Pridopidine or a pharmaceutically acceptable salt thereof are administered simultaneously.
19. The method of claim 1 , wherein the subject is a human patient.
20. A pharmaceutical composition comprising an amount of Tetrabenazine or pharmaceutically acceptable salt thereof, an amount of Pridopidine or pharmaceutical acceptable salt thereof, and at least one pharmaceutical acceptable carrier.
21. The pharmaceutical composition of claim 20 , wherein the amount of Tetrabenazine or pharmaceutically acceptable salt thereof is 5-100 mg.
22. The pharmaceutical composition of claim 20 , wherein the amount of Pridopidine or pharmaceutical acceptable salt thereof is 10-100 mg.
23. The method of claim 3 , wherein the amount of Tetrabenazine or a pharmaceutically acceptable salt thereof is administered via oral administration.
24. The method of claim 3 , wherein the amount of Tetrabenazine or a pharmaceutically acceptable salt thereof is administered daily, twice daily or three times daily.
25. The method of claim 3 , wherein the amount of Tetrabenazine or a pharmaceutically acceptable salt thereof is 0.05 mg/kg per day to 0.20 mg/kg per day.
26. The method of claim 3 , wherein the amount of Tetrabenazine or a pharmaceutically acceptable salt thereof is 1-500 mg/day.
27. The method of claim 3 , wherein the amount of Pridopidine or a pharmaceutically acceptable salt thereof is administered via oral administration.
28. The method of claim 3 , wherein the amount of Pridopidine or a pharmaceutically acceptable salt thereof is administered daily or twice daily.
29. The method of claim 3 , wherein the amount of Pridopidine or a pharmaceutically acceptable salt thereof is 1.5 μmol/kg per day to 20 μmol/kg per day.
30. The method of claim 3 , wherein the amount of Pridopidine or a pharmaceutically acceptable salt thereof is 1-500 mg/day.
31. The method of any one of claim 5 , wherein the movement disorder is Huntington's disease, Tourette's syndrome, or tardive dyskinesia.
32. The method of claim 3 , wherein the amount of Tetrabenazine or a pharmaceutically acceptable salt thereof and the amount of Pridopidine or a pharmaceutically acceptable salt thereof is effective to alleviate a symptom of the movement disorder.
33. The method of claim 32 , wherein the symptom is chorea.
34. The method of claim 3 , wherein the subject is receiving Tetrabenazine therapy prior to initiating administration of Pridopidine or a pharmaceutically acceptable salt thereof.
35. The method of claim 3 , wherein the amount of Tetrabenazine or a pharmaceutically acceptable salt thereof and the amount of Pridopidine or a pharmaceutically acceptable salt thereof are administered simultaneously.
36. The method of claim 3 , wherein the subject is a human patient.