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Claims for Patent: 8,354,437

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Claims for Patent: 8,354,437

Title:Method of using sustained release aminopyridine compositions
Abstract: A pharmaceutical composition which comprises a therapeutically effective amount of a aminopyridine dispersed in a release matrix, including, for example, a composition that can be formulated into a stable, sustained-release oral dosage formulation, such as a tablet which provides, upon administration to a patient, a therapeutically effective plasma level of the aminopyridine for a period of at about 12 hours and the use of the composition to treat various neurological diseases, including multiple sclerosis. A method of selecting individuals based on responsiveness to a treatment, including, for example, identifying individuals who responded to treatment with a sustained release fampridine composition.
Inventor(s): Blight; Andrew R. (Mahopac, NY), Cohen; Ron (Irvington, NY)
Assignee: Acorda Therapeutics, Inc. (Ardsley, NY)
Application Number:11/102,559
Patent Claims: 1. A method of increasing walking speed in a human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release composition of 10 milligrams of 4-aminopyridine twice daily for a time period of at least two weeks, wherein said 10 milligrams of 4-aminopyridine twice daily are the only doses of 4-aminopyridine administered to said patient during said time period.

2. A method of improving walking in a human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release composition of 10 milligrams of 4-aminopyridine twice daily for a time period of at least two weeks, wherein said 10 milligrams of 4-aminopyridine twice daily are the only doses of 4-aminopyridine administered to said patient during said time period.

3. A method of improving lower extremity muscle tone in a human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release composition of 10 milligrams of 4-aminopyridine twice daily for a time period of at least two weeks, wherein said 10 milligrams of 4-aminopyridine twice daily are the only doses of 4-aminopyridine administered to said patient during said time period.

4. A method of improving lower extremity muscle strength in a human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release composition of 10 milligrams of 4-aminopyridine twice daily for a time period of at least two weeks, wherein said 10 milligrams of 4-aminopyridine twice daily are the only doses of 4-aminopyridine administered to said patient during said time period.

5. The method of claim 1 wherein said time period comprises twelve weeks.

6. The method of claim 2 wherein said time period comprises twelve weeks.

7. The method of claim 3 wherein said time period comprises twelve weeks.

8. The method of claim 4 wherein said time period comprises twelve weeks.

9. The method of claim 1 wherein said method comprises initiating treatment of said patient with 4-aminopyridine by orally administering said sustained release composition twice daily to said patient.

10. The method of claim 2 wherein said method comprises initiating treatment of said patient with 4-aminopyridine by orally administering said sustained release composition twice daily to said patient.

11. The method of claim 3 wherein said method comprises initiating treatment of said patient with 4-aminopyridine by orally administering said sustained release composition twice daily to said patient.

12. The method of claim 4 wherein said method comprises initiating treatment of said patient with 4-aminopyridine by orally administering said sustained release composition twice daily to said patient.

13. The method of claim 1 wherein twice daily is about every 12 hours.

14. The method of claim 2 wherein twice daily is about every 12 hours.

15. The method of claim 3 wherein twice daily is about every 12 hours.

16. The method of claim 4 wherein twice daily is about every 12 hours.

17. The method of claim 5 wherein twice daily is about every 12 hours.

18. The method of claim 1 wherein said sustained release composition is a tablet.

19. The method of claim 2 wherein said sustained release composition is a tablet.

20. The method of claim 3 wherein said sustained release composition is a tablet.

21. The method of claim 4 wherein said sustained release composition is a tablet.

22. The method of claim 18 wherein said tablet exhibits a release profile to obtain a C.sub.avSS of about 15 ng/ml to about 35 ng/ml.

23. The method of claim 19 wherein said tablet exhibits a release profile to obtain a .sub.CavSS of about 15 ng/ml to about 35 ng/ml.

24. The method of claim 20 wherein said tablet exhibits a release profile to obtain a C.sub.avSS of about 15 ng/ml to about 35 ng/ml.

25. The method of claim 21 wherein said tablet exhibits a release profile to obtain a C.sub.avSS of about 15 ng/ml to about 35 ng/ml.

26. The method of claim 1 further comprising a step of measuring walking speed of the patient.

27. The method of claim 4 further comprising a step of measuring lower extremity muscle strength of the patient.

28. The method of claim 1 wherein said patient has relapsing remitting multiple sclerosis.

29. The method of claim 2 wherein said patient has relapsing remitting multiple sclerosis.

30. The method of claim 3 wherein said patient has relapsing remitting multiple sclerosis.

31. The method of claim 4 wherein said patient has relapsing remitting multiple sclerosis.

32. A method of increasing walking speed in a human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release tablet of 10 milligrams of 4-aminopyridine at about every 12 hours for a time period of at least two weeks, wherein said 10 milligrams of 4-aminopyridine at about every 12 hours are the only doses of 4-aminopyridine administered to said patient during said time period.

33. A method of improving walking in a human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release tablet of 10 milligrams of 4-aminopyridine at about every 12 hours for a time period of at least two weeks, wherein said 10 milligrams of 4-aminopyridine at about every 12 hours are the only doses of 4-aminopyridine administered to said patient during said time period.

34. A method of improving lower extremity muscle tone in a human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release tablet of 10 milligrams of 4-aminopyridine at about every 12 hours for a time period of at least two weeks, wherein said 10 milligrams of 4-aminopyridine at about every 12 hours are the only doses of 4-aminopyridine administered to said patient during said time period.

35. A method of improving lower extremity muscle strength in a human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release tablet of 10 milligrams of 4-aminopyridine at about every 12 hours for a time period of at least two weeks, wherein said 10 milligrams of 4-aminopyridine at about every 12 hours are the only doses of 4-aminopyridine administered to said patient during said time period.

36. The method of claim 32 wherein said time period comprises twelve weeks.

37. The method of claim 33 wherein said time period comprises twelve weeks.

38. A method of treating walking disability in a human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release composition of 10 milligrams of 4-aminopyridine twice daily for a time period of at least two weeks, wherein said 10 milligrams of 4-aminopyridine twice daily are the only doses of 4-aminopyridine administered to said patient during said time period.

39. The method of claim 38 wherein said method comprises orally administering to said patient a sustained release tablet of 10 milligrams of 4-aminopyridine at about every 12 hours for a time period of at least two weeks.

40. The method of claim 39 wherein said time period comprises 12 weeks.
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