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news.NicOx will publish the detailed results from the first pivotal phase 3 study for naproxcinod (the 301 study) in an upcoming issue of Osteoarthritis and Cartilage, the official journal of the Osteoarthritis Research Society International (OARSI).
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The company said that the objective of the study was to evaluate the efficacy and safety of naproxcinod 375 mg bid and naproxcinod 750 mg bid compared with naproxen 500 mg bid and placebo bid in 918 patients with osteoarthritis (OA) of the knee.
Naproxcinod, the CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory drug-candidate developed for the relief of the signs and symptoms of OA, is currently under review by the FDA and the European Medicines Agency (EMA).
The FDA plans to hold a meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss naproxcinod’s New Drug Application (NDA) on May 12, 2010, and has set a target date of July 24, 2010 for the completion of its review.
NicOx is focused on the research, development and future commercialization of drug candidates. It is applying its nitric oxide-donating R&D platform to develop an internal portfolio of New Molecular Entities (NME) for the potential treatment of inflammatory, cardio-metabolic and ophthalmological diseases.
NicOx’s investigational compound naproxcinod, an NME and a first-in-class CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory drug candidate is developed for the relief of the signs and symptoms of osteoarthritis (OA). The FDA has set an action date of July 24, 2010, under the Prescription Drug User Fee Act (PDUFA).