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NicOx Announces Blood Pressure Analysis From 301 Phase 3 Study for Naproxcinod at EULAR
Date:6/13/2008

dpoint. The fact that significance has been observed in a single trial supports our confidence that a clear statistical differentiation will be obtained between naproxcinod and naproxen in the predefined pooled analysis of the OBPM data."

Two remaining phase 3 trials for naproxcinod are currently ongoing (the 302 and 303 studies) and their results are anticipated in the second half of 2008. Naproxcinod's effect on blood pressure, in comparison to naproxen and placebo, will also be assessed by OBPM in these trials, allowing NicOx to perform a predefined statistical analysis on the pooled OBPM data. NicOx projects the filing of a New Drug Application (NDA) for naproxcinod in mid-2009.

Results of the blood pressure analysis

At week 13, naproxcinod showed mean changes from baseline in systolic blood pressure, compared to naproxen, of minus 2.89 mmHg (p<0.05) for the 750 mg bid dose and -1.82 mmHg (p=0.12) for the 375 mg bid dose. For diastolic blood pressure, in terms of mean changes from baseline compared to naproxen, naproxcinod 750 mg bid was -1.79 mmHg (p<0.05) and naproxcinod 375 mg bid was -1.55 mmHg (p<0.05). At the week 13 time point, more individual patients on naproxcinod showed a decrease in blood pressure compared to patients on placebo and naproxen.

Assessment of efficacy in the trial

The presentation contains additional information on the efficacy outcome measures of the study, going beyond the top-line results announced in 2006 (see press release of October 27, 2006). The detailed results for the two doses of naproxcinod, naproxen and placebo on the WOMAC(TM) pain subscale, WOMAC(TM) function subscale and patients' overall rating of disease status, at 2, 6 and 13 weeks are being displayed in graphical form. The three co-primary endpoints of the study assessed these scores at 13 weeks, in comparison to baseline. Sensitivity and subgroup analyses confirmed the positive result on these co-primary endpoints. Additional effic
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SOURCE NicOx S.A.
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