Strong blood pressure profile for NicOx' naproxcinod

NicOx SA of France says that analysis of blood pressure data from the 301 Phase III study show a statistically-significant difference between its drug candidate naproxcinod and the approved painkiller naproxen in terms of the mean change from baseline in systolic and diastolic blood pressure at week 13 (p<0.05 for three out of four comparisons).

Commonly used non-steroidal anti-inflammatory drugs, such as naproxen, have the tendency to raise blood pressure to an extent that may increase the rate of serious cardiovascular adverse events, noted the French drug developer. Presented at the 2008 European League Against Rheumatism Congress in Paris, France, the top-line efficacy results from the 301 study show that both doses of naproxcinod (750mg and 375mg bid) were superior to placebo on all three co-primary efficacy endpoints (p<0.001).

Patients' blood pressure was also measured in the study, with a well defined standardized approach where investigators took office blood pressure measurements at each patient visit to the clinical site. The OBPM changes from baseline at week 13 were pre-defined safety endpoints of the study and the statistical analysis announced was conducted on a post hoc basis.