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Last Updated: January 29, 2022

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Claims for Patent: 8,895,618


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Summary for Patent: 8,895,618
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:14/451,282
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,895,618
Patent Claims: 1. A dosage form suitable for once-daily 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 the drug in the dosage form comprises an extended release form, and wherein the extended release form of the drug in 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 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 the drug in the dosage form comprises an extended release form, and wherein the extended release form of the drug in 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 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 the drug in the dosage form comprises an extended release form, and wherein the extended release form of the drug in 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 extended release form of the drug in 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 to 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 to 3, wherein the amount of drug is 100 to 500 mg.

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

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

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

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

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

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

12. The dosage form of any of claims 1 to 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.

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