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Last Updated: October 22, 2019

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Claims for Patent: 8,895,617

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Summary for Patent: 8,895,617
Title:Composition and method for treating neurological disease
Abstract: Disclosed are compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of amantadine. Methods of administering the same are also provided.
Inventor(s): Went; Gregory T. (Mill Valley, CA), Fultz; Timothy J. (Jasper, GA), Porter; Seth (San Carlos, CA), Meyerson; Laurence R. (Las Vegas, NV), Burkoth; Timothy S. (Lake Bluff, IL)
Assignee: Adamas Pharmaceuticals, Inc. (Emeryville, CA)
Application Number:14/451,273
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,895,617
Patent Claims: 1. A method comprising: orally administering to a human subject with Parkinson's disease a once-daily dose consisting of (i) 200 mg to 500 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, and (ii) at least one excipient, wherein the drug in the dose comprises an extended release form, and wherein the extended release form of the drug in the dose 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 the same quantity of the drug in an immediate release form, wherein the dC/dT values are measured in a single dose human pharmacokinetic study over the time period between 0 and 4 hours after administration.

2. A method comprising: orally administering to a human subject with Parkinson's disease a once-daily dose consisting of (i) 200 mg to 500 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, and (ii) at least one excipient, wherein the drug in the dose comprises an extended release form, and wherein the extended release form of the drug in the dose 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 the same quantity of the drug in an immediate release form, wherein the dC/dT values are measured in a single dose human pharmacokinetic study over the time period between administration and Tmax of the immediate release form.

3. A method comprising: orally administering to a human subject with Parkinson's disease a once-daily dose consisting of (i) 200 mg to 500 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, and (ii) at least one excipient, wherein the drug in the dose comprises an extended release form, and wherein the extended release form of the drug in the dose 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 the same quantity of the drug in an immediate release form, wherein the dC/dT of the extended release form of the drug in the dose is measured in a single dose human pharmacokinetic study over the time period between 2 hours and 4 hours after administration and the dC/dT provided by the same quantity of the drug in an immediate release form is measured in a single dose human pharmacokinetic study over the time period between administration and Tmax of the immediate release form.

4. The method of any of claims 1 to 3, wherein the amount of drug is 300 to 500 mg.

5. The method of any of claims 1 to 3, wherein at least 50% of the drug in the dose is in an extended release form.

6. The method of any of claims 1 to 3, wherein at least 75% of the drug in the dose is in an extended release form.

7. The method of any of claims 1 to 3, wherein at least 90% of the drug in the dose is in an extended release form.

8. The method of any of claims 1 to 3, wherein the dose additionally comprises the drug in an immediate release form.

9. The method of any of claims 1 to 3, the dose administered is therapeutically effective for the treatment of Parkinson's disease.

10. The method of any of claims 1 to 3, wherein the human subject with Parkinson's disease suffers from dyskinesia.

11. The method of claim 10, wherein the method reduces the frequency or severity of dyskinesia.

12. The method of claim 10, wherein the dyskinesia is levodopa-induced dyskinesia.

13. The method of any of claims 1 to 3, additionally comprising administering to the subject a pharmaceutically effective amount of levodopa/carbidopa.

14. The method of any of claims 1 to 3, wherein the dose provides a shift in amantadine Tmax of 2 hours to 16 hours relative to an immediate release form of amantadine, wherein the Tmax is measured in a single dose human pharmacokinetic study.

15. The method of any of claims 1 to 3, wherein the dose comprises an osmotic device which utilizes an osmotic driving force to provide extended release of the drug.

16. The method of any of claims 1 to 3, wherein the extent of drug bioavailability is maintained.

17. The method of any of claims 1 to 3, wherein the once-daily dose is administered at a therapeutically-effective dose from the onset of therapy.

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