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Last Updated: November 28, 2020

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Claims for Patent: 8,389,578

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Summary for Patent: 8,389,578
Title:Composition and method for treating neurological disease
Abstract: The invention provides methods and compositions for treating or preventing neurological disorders.
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. (San Francisco, CA)
Assignee: Adamas Pharmaceuticals, Inc (Emeryville, CA)
Application Number:11/286,448
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,389,578
Patent Claims: 1. A method of treating a patient with Parkinson's disease comprising orally administering to the patient a first agent and once-daily orally administering to the patient a second agent, said first agent comprising a therapeutically effective amount of levodopa/carbidopa in an immediate release form and said second agent consisting essentially of a therapeutically effective amount of amantadine or pharmaceutically acceptable salt thereof in an amount ranging from 200 mg to 500 mg in an extended release form, wherein: the amantadine or pharmaceutically acceptable salt thereof provides change in plasma concentration as a function of time (dC/dT) over a defined period between 0 and 4 hours after administration that is less than about 40% of the dC/dT of the same quantity of an immediate release form of amantadine over said defined time period, wherein the dC/dT is measured in a single dose human pharmacokinetic study.

2. The method of claim 1 wherein the amantadine is administered at a dose of 300 to 500 mg per day.

3. A method of reducing amantadine-related neurotoxicity in a patient with Parkinson's disease comprising orally administering to the patient a first agent and once-daily orally administering to the patient a second agent, said first agent comprising a therapeutically effective amount of levodopa/carbidopa in an immediate release form and said second agent consisting essentially of a therapeutically effective amount of amantadine or pharmaceutically acceptable salt thereof in an amount ranging from 200 mg to 500 mg in an extended release form, wherein: the extended release amantadine or pharmaceutically acceptable salt thereof provides a change in amantadine plasma concentration as a function of time (dC/dT) over a defined time period between 0 and 4 hours after administration that is less than about 40% of the dC/dT of the same quantity of an immediate release form of amantadine over said defined time period, wherein the dC/dT is measured in a single dose human pharmacokinetic study.

4. The method of claim 3, wherein the side effect is dizziness.

5. The method of claim 3, wherein the amantadine is administered at a dose of 300 to 500 mg per day.

6. A method of reducing levodopa/carbidopa-related CNS side effects in a patient with Parkinson's disease comprising orally administering to the patient a first agent and once-daily orally administering to the patient a second agent, said first agent comprising a therapeutically effective amount of levodopa/carbidopa in an immediate release form and said second agent consisting essentially of a therapeutically effective amount of amantadine or pharmaceutically acceptable salt thereof in an amount ranging from 200 mg to 500 mg in an extended release form, wherein: the extended release amantadine or pharmaceutically acceptable salt thereof provides a change in amantadine plasma concentration as a function of time (dC/dT) over a defined time period between 0 and 4 hours after administration that is less than about 40% of the dC/dT of the same quantity of an immediate release form of amantadine over said defined time period, wherein the dC/dT is measured in a single dose human pharmacokinetic study.

7. The method claim 3, wherein the levodopa/carbidopa-related side effects are dyskinesias.

8. The method of claim 3, wherein the amantadine is administered at a dose of 300 to 500 mg per day.

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