FDA supplemental approval for Gocovri as an adjunctive treatment to levodopa/carbidopa in Parkinson’s disease patients experiencing OFF episodes. Adamas Pharma

Adamas Pharmaceuticals, Inc., a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, announced it has received marketing authorization from the FDA for a supplemental New Drug Application for Gocovri (amantadine) extended release capsules, gaining a second indication for the product. Gocovri is now approved as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes, in addition to its indication for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Data from two pivotal, placebo-controlled Phase III clinical studies showed that treatment with Gocovri significantly reduced both OFF time and dyskinesia. This resulted in a clinically meaningful increase in good ON time in patients taking a levodopa-based medication for Parkinson’s disease. Additionally, Gocovri demonstrated sustained efficacy for at least two years in the Phase III, open-label EASE LID-2 study.