NicOx S.A. (COX) announced that the third pivotal phase 3 study for naproxcinod in patients with OA of the hip showed a highly statistically significant result on all three co-primary efficacy endpoints of the trial.
Naproxcinod 750 mg bid showed the same gastrointestinal (GI) adverse event rate and a similar blood pressure profile to placebo.
Naproxcinod is the most advanced compound in a novel class of anti-inflammatory agents known as Cyclooxygenase-Inhibiting Nitric Oxide Donators (CINODs).
Following the positive results from the 301 and 302 studies in patients with OA of the knee, 303 represents the third phase 3 study for naproxcinod to achieve p<0.001 on="" all="" three="" co-primary="" efficacy="">
The 303 study is also the final pivotal trial that NicOx plans to include in the submission of a New Drug Application to the US Food and Drug Administration in mid-2009.
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