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Orexigen® Therapeutics Presents Additional Contrave® Data from Phase 3 COR-II Trial on 24-Hour Ambulatory Blood Pressure Monitoring
Date:4/4/2011

NEW ORLEANS, April 4, 2011 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX) announced additional data that showed that overweight and obese patients treated with Contrave® (naltrexone sustained release (SR)/bupropion SR) maintained normal 24-hour circadian patterns over one year of treatment.  These data were from the ambulatory blood pressure monitoring (ABPM) sub-study of the COR-II trial that also showed weight loss and improvements in markers of cardiometabolic risk.  Data were presented at the 60th Annual Scientific Session of the American College of Cardiology (ACC) taking place in New Orleans.

"The observation that patients in this sub-study maintained normal circadian variation of blood pressure may be particularly relevant since a loss of the nocturnal lowering in blood pressure may predict a poor cardiovascular outcome," said Jorge Plutzky, M.D., Director of the Vascular Disease Prevention Program at Brigham and Women's Hospital.

Additional results showed Week 52 weight loss of 7.5% for subjects in the sub-study on Contrave as compared to 2.5% for subjects on placebo (P<0.001) and improvements, at Week 56, in waist circumference (-7.5cm vs. -2.3 cm; P<0.001), hs-CRP (-40.7% vs. -2.4%; P<0.01) and HDL-C (+4.4mg/dL vs. -0.6mg/dL; P<0.01) based on LOCF analyses.  

Study Design

The COR-II ABPM sub-study enrolled 182 of the 1496 subjects from the main trial, at nine U.S. sites.  Monitoring of ambulatory blood pressure in the sub-study was initiated prior to the intake of study drug and other morning medications and completed approximately 24-hours later at three time points during the study: baseline, Week 24 and Week 52. COR-II is one of the four Phase 3 trials supporting Orexigen's New Drug Application for Contrave.

About the Contrave Clinical Development Program


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SOURCE Orexigen Therapeutics, Inc.
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