In 2008, NicOx successfully completed the phase 3 clinical program for naproxcinod in patients with OA of the knee (the 301 and 302 studies) and hip (the 303 study), with all three studies achieving highly statistically significant results on all three co-primary efficacy endpoints (the WOMAC(TM) pain subscale, WOMAC(TM) function subscale and subject's overall rating of disease status), as well as good overall safety and tolerability.
- In July, the top-line results of the 52-week safety extension of the 301 study were reported, which revealed no unexpected safety findings and showed a good overall long term safety for both doses of naproxcinod. - The 302 study reported top-line results in 1020 knee-OA patients in September 2008. In addition to meeting the three co-primary endpoints at 13 weeks (p<0.001), both doses of naproxcinod (750 mg and 375 bid) were statistically non-inferior to naproxen 500 mg bid at 26 weeks, in terms of the mean change from baseline in the WOMAC(TM) pain and function subscales. - Top-line results from the 303 study in 810 patients with OA of the hip were reported in November. Naproxcinod 750 mg bid met all three co-primary efficacy endpoints with high statistical significance (p<0.001).
During 2008, NicOx successfully completed an extensive database describing naproxcinod's blood pressure profile in more than 3,000 patients, using Office Blood Pressure Measurements (OBPM) and Ambulatory Blood Pressure Monitoring (ABPM).
Naproxcinod shows positive blood pressure results in phase 3 pooled analysis
In December 2008, NicOx announced the top-line results of the pooled
blood pressure analysis from the phase 3 program (304). OBPM measurements
were taken in a rigorous and standardized manner in each of the pha
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