IP Library Granted Patent US 12,036,213
Granted Patent B2
US 12,036,213 · App. 17/315,667 · Granted Jul 16, 2024

Pridopidine for treating drug induced dyskinesias

Inventors: Michal Geva (Even-Yehuda, IL); Aric Orbach (Rehovot, IL); Michael Hayden (Herzliya, IL)
Assignee: PRILENIA NEUROTHERAPEUTICS LTD.
A61K31/451A61K9/0053A61K45/06A61P25/14A61P25/16A61K31/198
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Quick Facts
Patent No.
US 12,036,213
App. No.
17/315,667
Granted
Jul 16, 2024
Kind
B2
Abstract

The invention provides a method of treating a subject afflicted with a drug-induced movement disorder including levodopa-induced dyskinesia comprising periodically administering to the subject in need thereof an amount of pridopidine or pharmaceutically acceptable salt thereof effective to treat the subject. The invention further provides a method of treating a subject at risk of developing a drug-induced movement disorder, including levodopa-induced dyskinesia.

Claims (29)

1. A method of treating levodopa-induced dyskinesia (LID) in a subject in need thereof, comprising a combination therapy of administering to the subject pridopidine or pharmaceutically acceptable salt thereof, and amantadine.

2. The method of claim 1 , wherein the subject is afflicted with Parkinson's disease.

3. The method of claim 1 , wherein the subject is afflicted with parkinsonism other than Parkinson's disease.

4. The method of claim 1 , wherein the subject is concurrently being treated with levodopa.

5. The method of claim 4 wherein the pridopidine, amantadine and the levodopa are administered sequentially or contemporaneously.

6. The method of claim 4 wherein the pridopidine and amantadine are administered after the levodopa is administered for a period of time.

7. The method of claim 6 , wherein the period of time is from 10 min to 18 hours.

8. The method of claim 7 , wherein the period of time is 10 min, 20 min, 30 min, 45 min, 1.0 hour, 2.0 hours, 6.0 hours, or 12 hours or 18 hours.

9. The method of claim 1 , wherein the pridopidine and amantadine are administered sequentially or contemporaneously.

10. The method of claim 1 wherein pridopidine and the amantadine are co-formulated.

11. The method of claim 1 , wherein the pridopidine and the amantadine are administered in a separate pharmaceutical formulation.

12. The method of claim 4 , wherein the levodopa is administered after the pridopidine and amantadine are administered for a period of time.

13. The method of claim 1 , wherein the method further alleviates or reduce a symptom associated with the levodopa treatment.

14. The method of claim 1 , pridopidine or pharmaceutically acceptable salt thereof and amantadine have synergistic activity and are effective to alleviate or reduce a symptom associated with the levodopa treatment.

15. The method of claim 13 , wherein the symptom is abnormal movements, myoclonic jerks, irregular movements of extremities, gait, facial grimacing, ataxia, inability to sustain motor act, hand movement or balance, choreiform peak dose dyskinesia, or dystonic peak dose dyskinesia.

16. The method of claim 13 , wherein the symptom is bad quality on-time evoked by levodopa.

17. The method of claim 13 , wherein the administration of pridopidine and amantadine improves the symptom of the levodopa induced dyskinesia by at least 8%, by at least 20%, by at least 30% or by at least 50% as measured by MDS-UPDRS or UDysRS.

18. The method of claim 1 , wherein the pridopidine or pharmaceutically acceptable salt thereof and amantadine are administered via oral administration.

19. The method of claim 1 , wherein pridopidine or pharmaceutically acceptable salt thereof, and amantadine are administered once daily, twice daily, three times daily, four times daily, or less than once a day.

20. The method of claim 1 , wherein pridopidine is administered as a pridopidine salt.

21. The method of claim 19 , wherein the salt is pridopidine HCl salt.

22. The method of claim 1 , wherein pridopidine is administered in a daily dose of between 10-400 mg/day.

23. The method of claim 1 , wherein pridopidine is administered in a daily dose of between 150-400 mg/day.

24. The method of claim 1 , wherein the pridopidine is administered at a daily dose of 200 mg given in the form of pridopidine HCl.

25. The method of claim 1 , wherein the method further delays the onset of LID or reduce the risk of developing LID.

26. The method of claim 1 , wherein the subject is receiving levodopa for treatment of Parkinson's disease.

27. The method of claim 1 , wherein the pridopidine or pharmaceutically acceptable salt thereof is administered in equal doses, twice daily.

28. The method of claim 1 , wherein amantadine is administered at a daily dose of between 10 mg to 400 mg/day.

29. The method of claim 1 , wherein the weight ratio between the pridopidine and amantadine is between 1:20 to about 20:1.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 13, 2021
From: GEVA, MICHAL; ORBACH, ARIC; HAYDEN, MICHAEL
To: PRILENIA NEUROTHERAPEUTICS LTD.
Reel/Frame 056831/0015 →