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Last Updated: January 20, 2020

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Claims for Patent: 8,895,614

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Summary for Patent: 8,895,614
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 Pharmaceuticals, Inc. (Emeryville, CA)
Application Number:14/328,440
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,895,614
Patent Claims: 1. A dosage form suitable for once-daily oral administration to a human subject consisting of (i) 50 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 at least 50% of the drug in the dosage form is in an extended release form, and wherein the dosage form 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 dosage form suitable for once-daily oral administration to a human subject consisting of (i) 50 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 at least 50% of the drug in the dosage form is in an extended release form, and wherein the dosage form 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 dosage form suitable for once-daily oral administration to a human subject consisting of (i) 50 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 at least 50% of the drug in the dosage form is in an extended release form, and wherein the dosage form 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 dosage form 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 dosage form of any of claims 1-3, comprising an osmotic device, which utilizes an osmotic driving force to provide extended release of amantadine.

5. The dosage form of any of claims 1-3, wherein the amount of drug is 100 to 500 mg.

6. The dosage form of any of claims 1-3, wherein the amount of drug is 200 to 500 mg.

7. The dosage form of any of claims 1-3, wherein at least 75% of the drug in the dosage form is in an extended release form.

8. The dosage form of any of claims 1-3, wherein at least 90% of the drug in the dosage form is in an extended release form.

9. The dosage form of any of claims 1-3, wherein the dosage form 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.

10. The dosage form of any of claims 1-3, wherein the extent of drug bioavailability is maintained.

11. The dosage form of any of claims 1-3, any of, wherein the dosage form additionally comprises the drug in an immediate release form.

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