Amantadine delayed release/extended release capsules significantly reduce OFF time in Parkinson's disease.

ABSTRACT: Maintaining consistent levodopa benefits while simultaneously controlling dyskinesia can be difficult. Recently, an amantadine delayed release/extended release (DR/ER) formulation (Gocovri^®) indicated for dyskinesia received additional FDA approval as an adjunct to levodopa for the treatment of OFF episodes. We evaluated OFF time reductions with amantadine-DR/ER in a pooled analysis of two phase III amantadine-DR/ER trials (NCT02136914, NCT02274766) followed by a 2-year open-label extension trial (NCT02202551). OFF outcomes were analyzed for the mITT population, as well as stratified by baseline OFF time of ≥2.5 h/day or <2.5 h/day. At Week 12, mean placebo-subtracted treatment difference in OFF time was -1.00 [-1.57, -0.44] h in the mITT population (n = 196), -1.2 [-2.08, -0.32

SUBMITTER: Hauser RA 

PROVIDER: S-EPMC8933492 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature