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Last Updated: November 26, 2020

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Claims for Patent: 9,918,973

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Summary for Patent: 9,918,973
Title:Sustained release aminopyridine composition
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 least 12 hours, preferably 24 hours or more and the use of the composition to treat various neurological diseases.
Inventor(s): Blight; Andrew R. (Mahopac, NY), Cohen; Ron (Irvington, NY)
Assignee: Acorda Therapeutics, Inc. (Ardsley, NY)
Application Number:15/482,412
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 a single administration of said sustained release composition of 10 milligrams of 4-aminopyridine to a human provides a maximum observed plasma concentration of 4-aminopyridine in a range of 27.7.+-.9.1 ng/mL.

2. The method of claim 1, wherein said time period comprises 12 weeks.

3. The method of claim 1, wherein said sustained release composition provides a mean T.sub.max in a range of about 2 to about 5.2 hours after administration of the composition to the patient.

4. The method of claim 1, wherein said sustained release composition of 10 milligrams of 4-aminopyridine is administered without a prior period of 4-aminopyridine titration, and without a subsequent period of 4-aminopyridine titration.

5. The method of claim 1, wherein the twice daily administering is administering at 12-hour intervals.

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

7. 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 twice daily administration of said sustained release composition of 10 milligrams of 4-aminopyridine to a human provides a maximum observed plasma concentration of 4-aminopyridine at steady state in a range of 32.2.+-.8.9 ng/mL.

8. The method of claim 7, wherein said time period comprises 12 weeks.

9. The method of claim 7, wherein said sustained release composition provides a mean T.sub.max in a range of about 2 to about 5.2 hours after administration of the composition to the patient.

10. The method of claim 7, wherein said sustained release composition of 10 milligrams of 4-aminopyridine is administered without a prior period of 4-aminopyridine titration, and without a subsequent period of 4-aminopyridine titration.

11. The method of claim 7, wherein the twice daily administering is administering at 12-hour intervals.

12. The method of claim 7, wherein said sustained release composition is a tablet.

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