FDA to review Orexigen's obesity treatment

SAN DIEGO The Food and Drug Administration has accepted a new drug application from a biopharmaceutical company focused on the treatment of obesity.

Orexigen said its investigational obesity treatment Contrave (naltrexone SR/bupropion SR), which addresses both physiological and behavioral drivers of the disease, was accepted by the FDA, following its Contrave Obesity Research clinical program, which included more than 4,500 patients.

"We are pleased the FDA has accepted our NDA for filing and look forward to working with the agency during the review process," said Michael Narachi, Orexigen president and CEO. "If approved, we believe Contrave will become an important therapeutic option for obese patients, making weight loss and weight maintenance an achievable cornerstone in the treatment of obesity and its common co-morbidities."

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