Posted by Michael Wonder on 11 Jul 2019
Neurocrine Biosciences announces FDA acceptance of new drug application for opicapone as an adjunctive treatment for patients with Parkinson's disease
10 July 2019 - New drug application based on data from 38 clinical studies, including two Phase III studies, with more than 1,000 Parkinson's disease patients treated with opicapone.
Neurocrine Biosciences today announced that the U.S. FDA has accepted its new drug application for opicapone, a novel, once-daily, oral, selective catechol-O-methyltransferase (COMT) inhibitor as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes.
The FDA has set a standard 12 month review process with a Prescription Drug User Fee Act target action date of 26 April 2020.
