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NicOx' Naproxcinod Shows Robust Blood Pressure Results in Phase 3 Pooled Analysis
Date:12/17/2008

"The present results for naproxcinod reinforce those of previous studies and show a similar blood pressure profile to placebo in a large population of chronically treated OA patients from three major phase 3 studies. They also reveal that naproxcinod is less likely to elevate blood pressure than naproxen, a commonly used NSAID. Increasing appreciation of the prevalence of hypertension amongst OA patients and its relevance as a complication of NSAID use suggest that naproxcinod will be an attractive new option for physicians."

NicOx has completed a regulatory phase 3 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 (see press releases of June 13, September 15 and November 24, 2008). NicOx plans to submit a New Drug Application (NDA) for naproxcinod to the US Food and Drug Administration (FDA) in mid-2009.

The top-line results announced today relate to the Office Blood Pressure Measurements (OBPMs) collected in a rigorous and standardized manner in each of the phase 3 studies at baseline and at weeks 2, 6 and 13 (see NOTE 1). This OBPM data was pooled and analyzed according to a prospectively designed statistical plan.

The objective of this pooled analysis was to evaluate the profile of naproxcinod 375 mg bid and 750 mg bid on blood pressure in a large OA population up to and including 13 weeks, compared to placebo and naproxen 500 mg bid. The statistical analysis plan pre-specified the calculation of 95% CIs and the statistical methods used to make these comparisons (see NOTE 2). The calculation of p values was not planned, although they have been included in this press release for illustrative purposes.

Naproxcinod 750 mg bid lowered SBP and DBP compared to naproxen with high statistical significance (p<0.001)'/>"/>

SOURCE NicOx
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Related medicine technology :

1. Third Pivotal Phase 3 Study for NicOx Naproxcinod Shows Positive Efficacy, Safety and Blood Pressure Results
2. NicOx Announces Favorable Blood Pressure Data for Naproxcinod in a Large ABPM Study
3. NicOx Announces Second Naproxcinod Pivotal Phase 3 Study (302) Meets Efficacy Primary Endpoints and Supports Non-Detrimental Blood Pressure Effect
4. NicOx Announces Top-Line Results From Naproxcinod 52-Week 301 Safety Extension
5. NicOx Completes Enrollment of Two Ambulatory Blood Pressure Measurement (ABPM) Studies for Naproxcinod in Hypertensive OA Patients
6. NicOx Announces Blood Pressure Analysis From 301 Phase 3 Study for Naproxcinod at EULAR
7. NicOx Completes Patient Enrollment in Third Naproxcinod Pivotal Phase 3 Study
8. NicOx Announces Initiation of First Phase 1 Study of Investigational Nitric Oxide-Donating Agent in Hypertensive Patients by Merck & Co., Inc.
9. Financial Results for Full Year 2007: NicOx Significantly Advances Clinical Programs
10. NicOx Announces Pfizer Initiates Phase 2 Clinical Development for PF-03187207 in Japan
11. NicOx Completes Enrollment in Second Pivotal Phase 3 Study for Naproxcinod and Provides Development Update
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