Third Pivotal Phase 3 Study for NicOx' Naproxcinod Shows Positive Efficacy, Safety and Blood Pressu... (ear efficacy in this difficult typeof os...)

Third Pivotal Phase 3 Study for NicOx' Naproxcinod Shows Positive Efficacy, Safety and Blood Pressure Results

Date:11/24/2008

ear efficacy in this difficult type of osteoarthritis patients and showing the same GI adverse event rate as placebo. 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."

Design and results of the 303 study

The 303 study was a 13-week, double-blind, placebo and naproxen controlled trial in patients with OA of the hip. 810 patients were enrolled at 120 clinical centers in the United States, Canada and Europe. Eligible patients had a diagnosis of primary osteoarthritis of the hip of at least three months in duration and were randomized on a 2:2:1 basis to receive naproxcinod 750 mg bid, placebo bid and naproxen 500 mg bid, respectively.

The three co-primary endpoints of the study compared the efficacy of naproxcinod 750 mg bid to placebo, in terms of the mean change between baseline and week 13 in the following scores: the WOMAC(TM) pain subscale, the WOMAC(TM) function subscale and the subject's overall rating of disease status. The results demonstrated that naproxcinod was superior to placebo with high statistical significance (p<0.001) on all three of these co-primary endpoints. These were the same endpoints as those used in the 301 and 302 phase 3 studies. No statistical comparison was made between naproxen 500 mg bid and the other two arms on the efficacy endpoints, due to the 2:2:1 randomization in the study, although numerical data show that naproxcinod 750 mg bid behaved in a similar fashion to naproxen 500 mg bid on these efficacy scores. NicOx entered into a full-service agreement for the conduct of the 303 study with Covance Inc., a global contract research organizati
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