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news.NicOx has announced the top-line results from the 52-week open label safety extension that was conducted following the completion of the 301 Phase III study for naproxcinod.
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The results revealed no unexpected safety findings and efficacy was maintained for the one-year duration of the study, as measured by the patients’ global assessment scale.
In addition, the results showed that the patients’ mean blood pressure was stable for 52 weeks following the completion of the 301 study, suggesting that naproxcinod does not increase blood pressure over time.
The 301 safety extension study was conducted in 92 clinical centers in the US and enrolled the first 500 eligible patients with osteoarthritis of the knee who successfully completed the 301 Phase III study for naproxcinod. NicOx expects to announce the top-line efficacy results from the ongoing 302 and 303 pivotal Phase III studies for naproxcinod in the second half of 2008, ahead of a projected new drug application in mid-2009.
The 302 study is being conducted in patients with osteoarthritis of the knee and efficacy is being measured at 13 weeks by the same three co- primary endpoints as in the 301 and 303 studies. In addition, the 302 trial is designed to generate one-year safety data for both doses of naproxcinod, with naproxen 500mg bid as an active comparator arm.
Naproxcinod is NicOx’s lead investigational drug and the first compound in the Cyclooxygenase-inhibiting nitric oxide donator (CINOD) class, which NicOx is developing for the treatment of the signs and symptoms of osteoarthritis.