Orexigen Therapeutics Phase IIb trial for Empatic meets primary efficacy endpoint demonstrating significantly greater weight loss versus comparators in obese patients.

Orexigen Therapeutics Inc announced that its 24-week, Phase IIb trial for Empatic (bupropion SR/zonisamide SR), the company's second late stage investigational combination drug for the treatment of obesity, met its primary efficacy endpoint by demonstrating statistically significantly greater weight loss for both Empatic doses compared to monotherapies and placebo. The company plans to meet with the US Food and Drug Administration (FDA) for an End of Phase II meeting to discuss these data with the goal of defining a Phase III plan for Empatic. Key top-line data from this study include the following: Patients completing 24 weeks of Empatic 360 (bupropion SR 360 mg/zonisamide SR 360 mg) …