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FDA Blocks Obesity Drug Over Cardiac Concerns

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The U.S. Food and Drug Administration (FDA) has told Orexigen Therapeutics Inc. in San Diego, California and Takeda Pharmaceutical Company Limited in Osaka, Japan that the agency is withholding approval of the companies’ candidate obesity management drug Contrave pending results of another clinical trial to address risks of heart disease. The companies released excerpts from the FDA letter today.

Contrave is an investigational compound, consisting of naltrexone and bupropion. Orexigen and Takeda developed the drug to help people with obesity initiate and sustain weight loss of at least 5 percent of their starting body weight in one year.

The FDA letter expressed concern about the cardiovascular safety of the naltrexone/bupropion compound when used long-term in a population of overweight and obese subjects. The letter released by the companies called for a “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.”

According to Orexigen, Contrave was submitted for U.S. regulatory approval in March 2010, based on multiple clinical trials that evaluated Contrave in more than 4,500 patients. In December 2010, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 7 to recommend the drug for approval. At the time, the panel also recommended a separate clinical trial to test for adverse cardiovascular events, but as a post-approval rather than pre-approval requirement.

Read more: Collaboration to Research Obesity Biomarkers, Drug Targets

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