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

Maintaining consistent levodopa benefits while simultaneously controlling dyskinesia can be difficult. Recently, an amantadine delayed release/extended release (DR/ER) formulation (Gocovri(R)) 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.

Automated summary

Maintaining consistent levodopa benefits while controlling dyskinesia can be difficult. A recent study evaluated the efficacy of an extended-release amantadine formulation as an adjunct to levodopa for the treatment of OFF episodes. The results showed significant reductions in OFF time in both the overall population and subgroups with different baseline OFF times.