The FDA Arthritis Drugs Advisory Committee and Drug Safety and Risk Management Committee based their recommendation on a review of data from the Naproxcinod clinical development program, which included 35 clinical studies involving more than 6,500 subjects.
The new drug application (NDA) file contains data from three large pivotal Phase 3 studies, all of which met their co-primary efficacy endpoints.
The FDA said that it is not bound by the recommendations of the Advisory Committee but may take their advice into consideration when evaluating the NDA for Naproxcinod. The FDA is expected to make a decision on whether to approve Naproxcinod by July 24, 2010.
Reportedly, NicOx submitted a marketing authorisation application (MAA) for Naproxcinod to the European Medicines Agency (EMA) in December 2009.