18 November 2009 - French biopharmaceutical company NicOx SA (EPA: COX) said today that it has been notified by the US Food and Drug Administration (FDA) that the New Drug Application (NDA) for naproxcinod is accepted for filing.

NicOx submitted the NDA on 24 September, seeking approval for the relief of the signs and symptoms of osteoarthritis. Based on the Prescription Drug User Fee Act (PDUFA), the agency will complete its review 10 months after submission and has set an action date of 24 July 2010.

Naproxcinod is the company's lead investigational compound and the first in a new class of anti-inflammatory agents known as CINODs (Cyclooxygenase- Inhibiting Nitric Oxide Donators). The naproxcinod NDA file is supported by data from a large programme of 34 clinical trials that involved more than 4,000 subjects. The programme 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 said it intends to submit a Marketing Authorisation Application (MAA) for naproxcinod to the European Medicines Agency (EMEA) by the end of 2009.

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