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NicOx Releases Naproxcinod Phase 3 Blood Pressure Results

NicOx, a pharmaceutical company focused on the research, development and future commercialisation of drug candidates, has released blood pressure results for Naproxcinod at an oral session of the American Society of Hypertension (ASH) Annual Scientific Meeting and Exposition in New York.

The study was presented by William White, professor of school of medicine at University of Connecticut.

Naproxcinod is the CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory drug-candidate developed for the relief of the signs and symptoms of osteoarthritis. It is currently under review by the FDA and marketing authorisation application (MAA) to the European Medicines Agency (EMA). The FDA has set an action date of July 24, 2010, under the prescription drug user fee act (PDUFA).

Naproxcinod is derived from naproxen but substituted with a nitroxybutyl ester to allow it to also act as a nitric oxide (NO) donor. The second mechanism of action makes Naproxcinod, the cyclooxygenase inhibiting nitric oxide donators (CINODs), that are hoped to produce similar analgesic efficacy to traditional NSAIDs, but with less gastrointestinal and cardiovascular side effects.

In his presentation, professor William White described previously undisclosed results from the pre-specified pooled analysis of the three pivotal Phase 3 trials for naproxcinod (the 301, 302 and 303 studies).