Orexigen(R) Therapeutics Phase 2b Trial for Empatic(TM) Meets Primary Efficacy Endpoint Demonstrating Significantly Greater Weight Loss Versus Comparators in Obes...(across the United States and incorporate...),Health

Date:9/30/2009

across the United States and incorporated a typical diet and exercise regimen. Patients enrolled in this trial had a body mass index (BMI) of 30 to 45, or as low as 27 in the presence of hypertension or dyslipidemia. The trial studied six arms: placebo, one dose of bupropion monotherapy, two doses of zonisamide monotherapy and two doses of Empatic. The doses selected for this trial were based on results from earlier Phase 2 trials of Empatic.

The primary endpoint was to show greater weight loss with Empatic compared to its individual components and placebo, in accordance with the FDA guidance for combination products. Data were analyzed using intent-to-treat (ITT) last observation carried forward (LOCF) of all randomized patients who had at least one post-baseline observation while on study drug. Results showed:

• Mean weight loss for Empatic360 (bupropion SR 360mg / zonisamide SR 360mg) was 7.5% versus 2.3% for bupropion 360 and 5.3% for zonisamide 360 (p<0.001).
• Mean weight loss for Empatic120 (bupropion SR 360mg / zonisamide SR 120mg) was 6.1% versus 2.3% for bupropion 360 and 3.2% for zonisamide 120 (p<0.001).
  

Results for the comparison of Empatic to placebo are detailed as follows:

    ITT-LOCF

                        Placebo    Empatic360         Empatic120

                         (N=75)      (N=164)            (N=81)

    Mean Weight Loss (%)   1.4%        7.5%*              6.1%*

    Greater than or
     equal to 5%
     weight loss (%)      14.7%       60.4%*             46.9%*

    Greater than or
     equal to 10%
     weight loss (%)       4.0%       32.3%*             24.7%*

    Completers (at 24 weeks)

                        Placebo    Empatic360         Empatic120

                         (N=53)      (N=109)            (N=54)

    Mean Weight Loss (%)   1.7%        9.9%*             7.7%*

    Mean Weight Loss (lbs) 4.4        21.9              1
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SOURCE  Orexigen Therapeutics, Inc.
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