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Last Updated: October 23, 2021

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Claims for Patent: 8,796,337


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Summary for Patent: 8,796,337
Title:Composition and method for treating neurological disease
Abstract: A method of administering amantadine is provided. The method comprises orally administering to a subject a pharmaceutical composition comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of the amantadine. A dose of the composition provides a mean change in amantadine plasma concentration as a function of time (dC/dT) that is less than 40% of the change in amantadine plasma concentration provided by a dose of the same quantity of an immediate release form of amantadine. The change in plasma concentration over time (dC/dT) is measured in a single dose human pharmacokinetic study in a defined time period of 0 to 4 hours after administration. The amantadine, or pharmaceutically acceptable salt thereof, is administered once daily at a dose of 300 to 500 mg per day.
Inventor(s): Went; Gregory T. (Mill Valley, CA), Fultz; Timothy J. (Pleasant Hill, CA), Porter; Seth (San Carlos, CA), Meyerson; Laurence R. (Las Vegas, NV), Burkoth; Timothy S. (Lake Bluff, IL)
Assignee: Adamas Pharmaceutical, Inc. (Emeryville, CA)
Application Number:13/958,153
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,796,337
Patent Claims: 1. A method of treating a human subject in need of amantadine therapy, comprising orally administering to the subject a pharmaceutical composition comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of the amantadine, or pharmaceutically acceptable salt thereof, from the pharmaceutical composition, wherein a dose of the composition provides a mean change in amantadine plasma concentration as a function of time (dC/dT) that is less than 40% of the dC/dT provided by a dose of the same quantity of an immediate release form of amantadine, wherein dC/dT is measured in a single dose human pharmacokinetic study in a defined time period of 0 to 4 hours after administration, and wherein the amantadine, or pharmaceutically acceptable salt thereof, is administered once daily at a dose of 300 to 500 mg per day.

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

3. The method of claim 1, wherein the controlled release amantadine has an in vitro dissolution profile in water of less than 20% in one hour, less than 30% in two hours, 40-80% in six hours, and greater than or equal to 80% in 12 hours as measured using a USP type II (paddle) dissolution system at 50 rpm, at a temperature of 37.+-.0.5 C.

4. The method of claim 3, wherein at least 95% of the amantadine, or pharmaceutically acceptable salt thereof, is in an extended release form.

5. The method of claim 1, wherein the amantadine, or pharmaceutically acceptable salt thereof, is administered at a dose of 300 to 400 mg per day.

6. The method of claim 1, wherein the amantadine, or pharmaceutically acceptable salt thereof, is administered at a dose of 400 to 500 mg per day.

7. A method of reducing the incidence of a treatment-induced debilitating side-effects in a human subject being treated for a CNS-related condition, comprising orally administering to the subject a pharmaceutical composition consisting essentially of amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of the amantadine, or pharmaceutically acceptable salt thereof, from the pharmaceutical composition, wherein a dose of the composition provides a mean change in amantadine plasma concentration provided as a function of time (dC/dT) that is less than 40% of the change in amantadine plasma concentration provided by a dose of the same quantity of an immediate release form of amantadine, wherein the dC/dT is measured in a single dose human pharmacokinetic study in a defined time period of 0 to 4 hours after administration, and wherein the amantadine, or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of 300 to 500 mg per day.

8. The method of claim 7, wherein the human subject is suffering Parkinson's disease.

9. The method of claim 7, wherein the controlled release amantadine has an in vitro dissolution profile in water of less than 20% in one hour, less than 30% in two hours, 40-80% in six hours, and greater than or equal to 80% in 12 hours as measured using a USP type II (paddle) dissolution system at 50 rpm, at a temperature of 37.+-.0.5 C.

10. The method of claim 7, wherein at least 95% of the amantadine, or pharmaceutically acceptable salt thereof, is in an extended release form.

11. The method of claim 7, wherein at least 95% of the amantadine, or pharmaceutically acceptable salt thereof, is administered at a dose of 300 to 400 mg per day.

12. The method of claim 7, wherein the amantadine, or pharmaceutically acceptable salt thereof, is administered at a dose of 400 to 500 mg per day.

13. The method of claim 1, wherein the human subject has a condition associated with Parkinson's disease selected from the group consisting of dementia, dyskinesia, dystonia, depression, fatigue, and other neuropsychiatric complications of Parkinson's disease.

14. The method of claim 8, wherein the human subject has a condition associated with Parkinson's disease selected from the group consisting of dementia, dyskinesia, dystonia, depression, fatigue, and other neuropsychiatric complications of Parkinson's disease.

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