The two pivotal Phase III studies in the opicapone clinical development program that formed the basis of the European marketing authorization application and approval are known as BIPARK-I and BIPARK-II. The BIPARK-I study was a placebo-controlled study of approximately 600 patients that also included entacapone as an active comparator. The BIPARK-II study was a placebo-controlled study of approximately 400 Parkinson’s patients. Both of the BIPARK Phase III trials included a one-year open-label extension.
In July 2019, Neurocrine Biosciences announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for opicapone 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 (PDUFA) target action date of April 26, 2020.