The FDA accepts for review Neurocrine Biosciences' (NASDAQ:NBIX) marketing application seeking approval to use opicapone, a once-daily, oral catechol-O-methyltransferase (COMT) inhibitor, for the adjunctive treatment (to levodopa/carbidopa) of Parkinson's disease patients experiencing OFF episodes.
The agency's action date is April 26, 2020.
The company in-licensed development and commercialization rights in the U.S. and Canada in 2017 from BIAL who markets opicapone in Europe under the brand name ONGENTYS (approved in June 2016).
