NicOx S.A. (NICXF.PK) said that the Joint Advisory Committees of the U.S. Food and Drug Administration or FDA voted by 16 to 1 with 1 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.
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, including 35 clinical studies involving over 6,500 subjects. The New Drug Application (NDA) file contains data from 3 large pivotal phase 3 studies, all of which met their co-primary efficacy endpoints.
The 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 FDA is anticipated to make a decision on whether to approve naproxcinod by July 24, 2010.
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