NicOx’s second Phase III osteoarthritis study meets endpoint

The study also comfortably met the main secondary endpoint, demonstrating that naproxcinod 750mg bid was statistically non-inferior to naproxen 500mg bid on the Womac pain and function subscales at week-13 and 26, the company said.

NicOx’s Phase III clinical program for naproxcinod consists of three pivotal trials (including the previously completed 301 study in osteoarthritis of the knee and the ongoing 303 study in osteoarthritis of the hip, in addition to the 302 study). Overall, the results of the 302 study support naproxcinod’s non-detrimental effect on blood pressure and are consistent with those observed in the 301 study, with naproxcinod 750mg bid showing a numerical reduction in systolic and diastolic blood pressure at week-13 and 26, compared to baseline and naproxen 500mg bid.

A post hoc pooled analysis of the blood pressure data from the 301 and 302 studies showed a statistically significant reduction for naproxcinod 750mg bid, compared to naproxen 500mg bid, in terms of the mean change from baseline at week-13, of 2.3 mmHg (p < > =0.004) for systolic blood pressure and 1.1mmHg (p < > =0.034) for diastolic blood pressure.

In the planning of the Phase III program, NicOx had foreseen the pooling of office blood pressure measurements from more than one study in order to obtain the necessary statistical power to correctly assess the effects of naproxcinod on blood pressure, compared to naproxen. A pre-specified analysis of the pooled blood pressure data from the three Phase III studies will be conducted following the completion of the third Phase III trial (the 303 study) in the fourth quarter of 2008.

As in the 301 study, both naproxcinod doses (375mg bid and 750mg bid) were shown to be superior to placebo on the three co-primary efficacy endpoints of the 302 trial, the Womac pain subscale, the Womac function subscale and patients’ overall rating of disease status, with these being highly statistically significant (p < 0.001) in terms of the mean change from baseline at week-13. The main secondary endpoint of the trial assessed the efficacy of naproxcinod 750mg bid to naproxen 500mg bid at week-13 and 26 in terms of the mean change from baseline in the Womac pain and function subscales. Naproxcinod 750mg bid comfortably met the secondary endpoint of being statistically non-inferior to naproxen 500mg bid on these two parameters.