NicOx announces positive results from Phase III osteoarthritis study

Naproxcinod 750mg bid showed the same gastrointestinal (GI) adverse event rate and a similar blood pressure profile to placebo. Following the positive results from the 301 and 302 studies in patients with osteoarthritis (OA) of the knee, 303 represents the third Phase III study for naproxcinod to achieve p<0.001 on all three co-primary efficacy endpoints. The 303 study is also the final pivotal trial that NicOx plans to include in the submission of a new drug application (NDA) to the FDA in mid-2009. The 303 study was a 13-week, double-blind, placebo and naproxen controlled trial in patients with OA of the hip. Approximately 810 patients were enrolled at 120 clinical centers in the US, Canada and Europe. Eligible patients had a diagnosis of primary OA of the hip of at least three months in duration and were randomized on a 2:2:1 basis to receive naproxcinod 750mg bid, placebo bid and naproxen 500mg bid, respectively. The blood pressure data for naproxcinod 750mg bid were consistent with those obtained in the 301 and 302 studies. Blood pressure was measured using standardized and controlled office blood pressure measurements at baseline and at weeks two, six and 13. At all time points, the patients treated with naproxcinod 750mg bid showed a very similar blood pressure profile to those on placebo. In addition, naproxcinod 750mg bid showed a clear reduction in systolic and diastolic blood pressure compared to naproxen 500mg bid at all time points. No stand-alone statistical analysis of the blood pressure data from the 303 study was pre-specified. Pascal Pfister, chief scientific officer and head of R&D at NicOx, said: "The blood pressure data are consistent with previous studies and we are keenly awaiting the important results of the pre-defined statistical analysis in the next few weeks, following the pooling of the 301, 302 and 303 blood pressure data. We are confident that these results will clearly demonstrate naproxcinod's non-detrimental blood pressure profile, in contrast to naproxen."