Strong 52-week safety data for naproxcinod

French drugmaker NicOx SA says that top-line results from a 52-week, open-label safety extension trial, following the completion of the 301 Phase III study for naproxcinod, revealed no unexpected safety findings. Efficacy was maintained for the one-year duration of the study, as measured by the patients' global assessment scale, the firm noted.

In addition, the results showed that the patients' mean blood pressure was stable for 52 weeks following the completion of the 301 study, suggesting that naproxcinod does not increase blood pressure over time, which could help differentiate the drug from other products used to treat chronic pain. NicOx' lead investigational drug is the first compound in the COX-inhibiting nitric oxide donator class, which the firm is developing for the treatment of the signs and symptoms of osteoarthritis.

NicOx expects to announce the top-line efficacy results from the ongoing 302 and 303 pivotal Phase III studies for naproxcinod in the second half of the year, ahead of a projected New Drug Application in mid-2009.