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-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments-
Date:7/20/2009

ceive either placebo or Contrave, BID, with a four week titration period. 

    COR-I (NB-301):  A trial designed to assess the safety, tolerability and
    efficacy of Contrave16 and Contrave32 versus placebo in 1,742 obese
    patients.  This trial incorporated a typical diet and exercise regimen and
    was conducted at 34 US centers.

                          Intent-To-Treat (N=1,453)      Completers (N=870)
                         28 weeks          56 weeks           56 weeks
                  Contrave32    PBO   Contrave32   PBO   Contrave32  PBO
                    (n=471)   (n=511)  (n=471)   (n=511)  (n=296)  (n=290)
    Mean Weight
     Loss (%)         6.1%*     1.7%     6.1%*    1.3%     8.1%*     1.8%
    Mean Weight
     Loss (lbs)      13.2*      3.8     13.3*     3.0     17.6*      4.1
    Greater than or
     equal to 5%
     weight
     loss (%)        52.9%*    17.4%    48.0%*   16.4%    61.8%*    23.1%

    * p<.001

    Contrave16 patients (n=471) experienced mean weight loss from baseline of
    5.4% and 5.0% at 28 and 56 weeks, respectively;  44.4% and 39.5% of
    patients lost greater than or equal to 5% of their body weight at 28 and
    56 weeks. All of these differences from placebo were highly statistically
    significant.



    COR-II (NB-303):  A trial designed to assess the safety, tolerability and
    efficacy of Contrave32 versus placebo in 1,496 obese patients.  After week
    28, patients not achieving 5% weight loss were re-randomized in a blinded
    fashion to assess whether increasing the dose to Contrave48 would result
    in additional weight loss.#  This trial incorporated a typical diet and
    exercise regimen and was conducted at 36 US centers.

                           Intent-To-Treat  (N=1,281)     Completers (N=701)
                          28 weeks+         56 weeks++          56 weeks++
                    Contrave32   PBO   Contrave32   PBO    Con
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SOURCE  Orexigen Therapeutics, Inc.
Copyright©2009 PR Newswire.
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