Naproxcinod superior to naproxen in Ph III OA trial

French drugmaker NicOx SA says that encouraging results from the first pivotal Phase III trial for naproxcinod in patients with osteoarthritis of the knee, the 301 study, were presented at the annual meeting of the American College of Rheumatology, in Boston, Massachusetts. The agent is the firm's lead investigational product and the first COX-inhibiting nitric oxide donator.

According to the company, the data showed that both doses of naproxcinod (750mg and 375mg bid) had superior efficacy to placebo at all time points (two, six and 13 weeks). This presentation also contained additional safety and tolerability information, including the gastro-intestinal adverse event rates and blood pressure measurements reported for each of the treatment groups.

Detailed clinical data from the 301 study were presented, including data for each of the three co-primary efficacy endpoints: WOMAC pain subscale, WOMAC function subscale and patients' overall rating of disease status. Each of the active treatments (naproxcinod 750mg, naproxcinod 375mg and naproxen 500mg bid) were statistically-significantly superior to placebo (p<=0.0002) at two, six and 13 weeks. In addition, standard quality of life scores showed a functional improvement for both naproxcinod doses, as well as for the naproxen group, NicOx noted.