NicOx Announces Top-Line Results From Naproxcinod 52-Week 301 Safety...(e 302trial is designed to generate one-y...),Health

Design and top-line results of the 301 extension study

The patient population characteristics in the safety extension were similar to the 301 phase 3 trial and were representative of the general osteoarthritis population. Patients who received placebo or naproxen 500 mg bid, during the 13-week active treatment period of the 301 phase 3 study, were randomized to receive either naproxcinod 750 mg or 375 mg bid for a further 52 weeks in the safety extension study. The patients who received naproxcinod 750 mg or 375 mg bid for 13 weeks continued with this same dosing regimen for an additional 52 weeks. The measurements taken at week-13 in the 301 study were used as the baseline for the 301 extension study.

The primary objective of the 301 extension study was to assess the long term safety of naproxcinod, with a particular focus on blood pressure. The results revealed no unexpected safety findings and showed a good overall long term safety for both doses of naproxcinod. Standardized controlled office blood pressure measurements (OBPM) were performed at each patient visit to the clinical site in both the 301 phase 3 study and the 301 safety extension. In the 301 study, naproxcinod showed a sustained reduction in systolic and diastolic blood pressure from baseline, at all time points including at 13 weeks. The data from the safety extension shows that overall the mean systolic and diastolic blood pressures at week 52 were similar compared to the mean values measured in patients starting the extension study, suggesting that both naproxcinod 750 mg and 375 mg bid do not increase blood pressure over time.

A secondary objective of the study was to assess efficacy, as measured by the patient global assessment scale, which revealed that efficacy was maintained until 52 weeks for both doses of naproxcinod.