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 pharmaceutical composition consisting of (i) 110 mg to 445 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof and (ii) at least one excipient, wherein said composition is suitable for once daily, oral administration to a human subject at a time such that the drug does not interfere with sleep, wherein at least one of said excipients modifies the release of the drug to provide an extended release form, and wherein administration of the composition 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-8-12 hrs to C-ave-0-8 hrs ratio of 1.1 to 2.0 as determined in a multiple dose human pharmacokinetic study.