FDA Accepts NDA For Naproxcinod

NicOx has received a filing communication from the FDA stating that the New Drug Application (NDA) for Naproxcinod is accepted for filing. NicOx submitted the NDA on September 24, seeking approval for the relief of the signs and symptoms of osteoarthritis.

Based on the Prescription Drug User Fee Act (PDUFA), the FDA will complete its review 10 months after submission and has set an action date of July 24, 2010.

Philippe Serrano, vice president of regulatory affairs at NicOx, said: “We are very pleased to receive this filing communication from the FDA and it is thanks to a collective effort by our entire R&D Department, which has provided a high-quality application. We believe that when approved, Naproxcinod could represent a valuable new treatment option for osteoarthritis patients.”

The Naproxcinod NDA file is supported by data from a large program of 34 clinical trials that involved more than 4,000 subjects. The program evaluated the efficacy of Naproxcinod in relieving signs and symptoms of osteoarthritis, as well as its safety. During its safety evaluation, particular care was given to its effect on blood pressure. NicOx plans to submit a Marketing Authorisation Application (MAA) for Naproxcinod to the EMEA by the end of 2009.