The blood pressure data for naproxcinod 750 mg bid were consistent with those obtained in the 301 and 302 studies. Blood pressure was measured using standardized and controlled office blood pressure measurements (OBPM) at baseline and at weeks 2, 6 and 13 (see NOTE). At all time points, the patients treated with naproxcinod 750 mg bid showed a very similar blood pressure profile to those on placebo. In addition, naproxcinod 750 mg bid showed a clear reduction in systolic and diastolic blood pressure (SBP and DBP) compared to naproxen 500 mg bid at all time points. No stand alone statistical analysis of the blood pressure data from the 303 study was pre-specified.
As planned, NicOx will pool the blood pressure data from the three phase 3 studies (301, 302 and 303) according to a prospectively designed protocol that has been submitted to the FDA. The Company will disclose the top-line results of the pre-specified statistical analysis on the pooled data in the coming weeks.
Naproxcinod and placebo show the same gastrointestinal (GI) adverse event rate
Naproxcinod 750 mg bid showed good overall safety and tolerability. The percentage of patients who experienced one or more GI adverse events was the same for placebo and naproxcinod 750 mg bid at 15.5%, compared to 19.2% for naproxen 500 mg bid. In terms of the percentage of patients who experienced at least one adverse event overall, this was lower for naproxcinod 750 mg than naproxen 500 mg bid. There was not a single serious cardiovascular or serious GI adverse event in the naproxcinod arm during the 13 weeks of the 303 study, in contrast to the placebo and naproxen 500 mg bid arms.
Pascal Pfister MD, Chief Scientific Officer and Head of Research and
Development at NicOx, commented: "We believe these are extremely good
results, with naproxcinod demonstrating cl
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