Orexigen Therapeutics, Inc announced that its 24-week, phase-2b 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-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."
"Obesity is a complex disease that is challenging to treat. What works for one patient may not work for another, making it critical to have a broad spectrum of interventions available for physicians and their patients," said Caroline Apovian, director of the Center for Nutrition and Weight Management, Boston Medical Center. "These phase-2 data show impressive weight loss among patients treated with Empatic and support further investigation to determine the full potential of Empatic."
These data follow the announcement by the company in July 2009 that phase-3 trials evaluating Contrave (bupropion SR/naltrexone SR), its lead investigational drug for the treatment of obesity, met their co-primary endpoints, exceeding the FDA categorical efficacy benchmark for clinically significant weight loss. The company remains on track to file a New Drug Application (NDA) for Contrave with the FDA in the first half of 2010.
Orexigen Therapeutics is a biopharmaceutical company focused on developing therapies that offer multiple approaches to treating obesity.