Composition and method for treating neurological disease

摘要

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.

主权项

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.