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.
Neurocrine Biosciences is in the process of preparing for a New Drug Application (NDA) submission which it anticipates will occur during the second quarter of 2019.