Naproxcinod reduces blood pressure in OA

French drug developer NicOx has reported positive results of a pre-specified pooled analysis of 2,734 patients with osteoarthritis from  the 301, 302 and 303 pivotal Phase III studies of its naproxcinod.

Both doses of the drug showed a significant reduction in systolic and  diastolic blood pressure (SBP and DBP) compared to naproxen 500mg over  the whole 13-week period (p<0.001 for naproxcinod 750mg and p <0.05 for  naproxcinod 375mg). The proportion of patients whose SBP increased by 5  mmHg or more was higher for naproxen 500mg, as compared to naproxcinod  750mg (p<0.001), naproxcinod 375mg (p=0.013) and placebo (p<0.001). Both  doses were similar to placebo, as indicated by one-sided 95% confidence  intervals. In contrast, naproxen 500mg raised SBP compared to placebo  (p<0.001).

NicOx plans to submit a New Drug Application for naproxcinod to the US  Food and Drug Administration in mid-2009. Further analyses are ongoing  and the firm plans to disclose more detailed results at leading medical  conferences and in peer-reviewed publications during 2009 and  2010.