Neurocrine: FDA Accepts Application for Adjunctive Parkinson’s Treatment

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) 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. Parkinson’s disease is a chronic, progressive and debilitating neurodegenerative disorder that affects approximately one million people in the U.S. The FDA has set a standard 12-month review process with a Prescription Drug User Fee Act (PDUFA) target action date of April 26, 2020.

https://www.marketscreener.com/NEUROCRINE-BIOSCIENCES-I-10163/news/Neurocrine-Biosciences-Announces-FDA-Acceptance-of-New-Drug-Application-for-Opicapone-as-an-Adjunc-28879847/