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] h in the ≥2.5 h subgroup (n = 102) and -0.77 [-1.49, -0.06] in the <2.5 h subgroup (n = 94). Amantadine-DR/ER-treated participants showed reduced MDS-UPDRS Part IV motor fluctuation subscores by week 2 that were maintained below baseline to Week 100.

• Authors: Robert A Hauser, Judy Lytle, Andrea E Formella, Caroline M Tanner
• Journal: NPJ Parkinson's disease (NPJ Parkinsons Dis) Vol. 8 Issue 1 Pg. 29 (Mar 18 2022) ISSN: 2373-8057 [Print] United States
• PMID: 35304480 (Publication Type: Journal Article)
• Copyright: © 2022. The Author(s).