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FDA Issues Complete Response Letter To NDA For Contrave For Obesity Management

Orexigen Therapeutics Inc. (OREX) and Takeda Pharmaceutical Company Ltd. announced that the United States Food and Drug Administration or FDA issued a complete response letter dated January 31, 2011 relating to the New Drug Application for Contrave or naltrexone HCl/bupropion HCl extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.

The FDA noted concern about the cardiovascular safety profile of naltrexone/bupropion when used long-term in a population of overweight and obese subjects. Specifically, the letter said that "before your application can be approved, you must conduct a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with naltrexone/bupropion does not adversely affect the drug's benefit-risk profile."

Michael Narachi, President and CEO of Orexigen noted, We are surprised and extremely disappointed with the Agency's request in light of the extensive discussion and resulting vote on this topic at the December 7 Advisory Committee meeting." Narachi continued, "We plan to work closely with the Agency to gain more information to determine the appropriate next steps regarding the Contrave application."

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