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Orexigen Therapeutics Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2012
Date:3/13/2013

NDA resubmission filing, would be supplied to the FDA during the review within 60 days of the NDA resubmission.

In February, Orexigen initiated enrollment and randomized 242 patients into the Ignite Study. The Ignite Study is an open-label clinical trial designed to provide additional information regarding the real world weight loss potential of Contrave in combination with a commercially available comprehensive lifestyle intervention program, compared to patients who receive usual care of diet and exercise advice from the study site staff but who do not receive Contrave. The primary endpoint for this trial is change in body weight after 26 weeks. Orexigen anticipates receiving results from the Ignite Study by year-end 2013.

  • Empatic™, a fixed dose combination of bupropion SR and zonisamide SR, for the treatment of obesity: In a series of discussions with the FDA on the continued development of Empatic, the FDA stated that Phase 3 data for Empatic may be sufficient to support submission of an NDA without data from a cardiovascular outcomes trial. The FDA indicated that as long as the placebo-subtracted changes in body weight, blood pressure and heart rate for Empatic are similar to or more favorable than the placebo-subtracted changes observed with Contrave, and there are no signals of cardiovascular concern in the Empatic development program, reassuring results of a cardiovascular outcomes trial with Contrave will be sufficient.  In addition, while the FDA reiterated the belief that the teratogenicity potential for zonisamide is very concerning, the FDA will allow Phase 3 studies of Empatic to include women of childbearing potential who have a Body Mass Index that meets the FDA definition of overweight (>27kg/m2) in the presence of at least one weight-related comorbidity. Orexigen owns worldwide rights to Empatic. Prior to initiating Phase 3 studies of Empatic, the Company plans to seek
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