NicOx SA announced that the Joint Advisory Committees of the US Food and Drug Administration (FDA), including the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, voted by 16 to one with one abstention that they did not have sufficient evidence at this time to support the approval of naproxcinod for the relief of the signs and symptoms of osteoarthritis.
Chair Dr Kathleen O'Neil MD, associate professor of Paediatrics, University of Oklahoma College of Medicine, Division of Rheumatology, summarized the findings of the Advisory Committee meeting, saying there was enthusiasm for the potential of naproxcinod but more data was required from additional safety studies. The US 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 US FDA is not bound by the recommendations of the Advisory Committee but may take their advice into consideration when evaluating the NDA for naproxcinod. The US FDA is expected to make a decision on whether to approve naproxcinod by July 24, 2010.
NicOx submitted a Marketing Authorization Application (MAA) for naproxcinod to the European Medicines Agency (EMA) in December 2009.
Naproxcinod is NicOx's lead investigational compound and the first in a new class of anti-inflammatory agents known as CINODs (Cyclooxygenase-Inhibiting Nitric Oxide Donators).