AMANTADINE COMPOSITIONS AND METHODS OF USE

摘要

Methods of nighttime administration of amantadine to reduce sleep disturbances in patient undergoing treatment with amantadine are described, as well as compositions of extended release amantadine that are suitable for nighttime administration.

主权项

1. A method of administering a dose of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof to a human subject orally, once daily at a time such that the drug does not interfere with sleep, wherein the dose consists of (i) 220 mg to 445 mg of the drug and at least one excipient, wherein at least one of said excipients modifies the release of the drug to provide an extended release form, and wherein administration of the dose provides a Tmax of 6 to 18 hours as measured in a single dose human pharmacokinetic study and once daily administration provides a C-ave-day to C-ave-night ratio of 1.1 to 1.9 as determined in a multiple dose human pharmacokinetic study.