NicOx completes enrollment for final trial of naproxcinod

French drug developer NicOx has completed patient enrollment for the final late-stage trial on its osteoarthritis of the hip treatment, naproxcinod, before its New Drug Application can be filed.

The trial, known as 303, is a 13-week, double-blind, placebo and naproxen controlled, Phase III study on 810 patients diagnosed with primary osteoarthritis of the hip for at least three months duration, in 120 clinical centers in the USA, Canada and parts of Europe. It is intended to provide further information on the efficacy of the drug in symptom treatment, as well as additional safety information regarding the compound's blood pressure profile.

Naproxcinod is one of a class of novel anti-inflammatory agents known as cyclo-oxygenase-inhibiting nitric oxide donators. CINODs are thought to be an alternative to non-steroidal anti-inflammatory drugs, the common treatment for the condition in question, yet are known to have a tendency to elevate blood pressure to unfavorable levels.