NicOx S.A. today announces that on Wednesday, May 12, 2010, the US Food and Drug Administration (FDA) plans to hold a meeting to discuss the New Drug Application (NDA) for naproxcinod.
NicOx submitted an NDA for naproxcinod to the FDA in September 2009, seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis (OA). Based on the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its review 10 months after submission and has set an action date of July 24, 2010.
“We believe naproxcinod could become an important treatment option for patients with osteoarthritis and the planned advisory committee meeting represents a very important milestone for NicOx,” stated Michele Garufi, Chairman and CEO of NicOx.
“We look forward to discussing the efficacy and safety data for naproxcinod with the members of the Arthritis Drugs and the Drug Safety and Risk Management Advisory Committees.”
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