Naproxcinod is in phase III clinical development for the treatment of the signs and symptoms of osteoarthritis.
Based on this current feedback and previous discussions held with the FDA, NicOx believes that its global registration plan for naproxcinod will be adequate to satisfy current requirements in the US with regards to demonstrating the efficacy and safety of naproxcinod for treating the signs and symptoms of osteoarthritis.
NicOx said that it plans to submit a new drug application and apply for marketing authorization for naproxcinod in the US and Europe in the first quarter of 2009.
Naproxcinod is an anti-inflammatory agent and the first compound in the COX-Inhibiting Nitric Oxide-Donating class. As with the development of any new molecular entity, additional safety studies could be required if any safety signals were to be observed in the development program.