Orexigen(R) Initiates Second Phase IIb Empatic(TM) Trial o...(lesterol and coronary artery disease amo...),Health

Date:7/9/2008

lesterol and coronary artery disease, among others. Research has shown that obesity has a greater impact on the development of chronic conditions in the U.S. than poverty, nicotine or alcohol abuse. Obesity also places a significant financial burden on the economy with mortality and morbidity costs estimated to exceed $100 billion annually.

Empatic combines zonisamide and bupropion, two existing drugs that have been independently approved by the U.S. Food and Drug Administration (FDA) to treat other central nervous system disorders. Orexigen has developed a proprietary sustained release (SR) formulation of zonisamide that has demonstrated a better tolerability profile than the legacy, immediate release (IR) formulation. These two drugs were selected based on their complementary activity in reducing appetite, increasing the body's burning of calories and sustaining weight loss.

The Company's other late-stage obesity product candidate, Contrave(R), is a combination of bupropion SR and naltrexone in a proprietary SR formulation that also appears to result in improved tolerability compared to the legacy naltrexone IR formulation. Contrave currently is being studied in four Phase III clinical trials that are fully enrolled. The program continues on schedule with initial results anticipated in late 2008 or early 2009 and the filing of a New Drug Application (NDA) with the FDA projected for late 2009.

Phase IIb Empatic Trial Details

ZB-202 is a randomized, double-blind, placebo-controlled trial involving approximately 720 generally healthy, nondiabetic obese patients at 20 sites nationwide. The primary endpoint for this trial is percent change in body weight after 24 weeks of blinded therapy. Patients will be randomized to one of six treatment groups including two of the Empatic doses associated with weight loss in the previous Phase IIb trial. The efficacy of Empatic will be compared against zonisamide monotherapy, bupropion monotherapy and pla
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SOURCE Orexigen Therapeutics, Inc. Copyright©2008 PR Newswire. All rights reserved

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