Orexigen® Therapeutics, Inc. (Nasdaq: OREX) today announced that its 24-week, Phase 2b trial for Empatic(TM) (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 U.S. Food and Drug Administration (FDA) for an End of Phase 2 meeting to discuss these data with the goal of defining a Phase 3 plan for Empatic.
"We believe that the Empatic Phase 2b results demonstrate early and meaningful weight loss that exceeds both the mean and categorical efficacy benchmarks set by the FDA for one year Phase 3 trials. Furthermore, the trajectory of weight loss at 24 weeks suggests that there may be additional therapeutic benefits in longer trials," said Mike Narachi, President and CEO of Orexigen. "These positive results affirm the strength of our obesity franchise and the potential to offer different mechanisms to treat this complex disease and meet the diverse needs of patients."
Key top-line data from this study include the following: