Three-Month Delay in US for Bupropion/Naltrexone for Obesity

June 11, 2014

The US Food and Drug Administration (FDA) has extended, by 3 months, its review of the combination of bupropion/naltrexone, developed by Orexigen Therapeutics, for the treatment of obesity. A decision is now expected by September 11, 2014.

The FDA first rejected the drug combination in February 2011, asking the company to conduct a cardiovascular-outcomes trial, because of concerns about the cardiovascular safety profile of naltrexone/bupropion when used long term in a population of overweight and obese subjects.

Orexigen Therapeutics subsequently began the 8900 patient Light Study, and following encouraging interim safety and outcomes data from this trial, the company resubmitted the US new drug application at the end of last year.

In a statement issued today, the company says the FDA has indicated that the review extension is needed to reach agreement on the postmarketing obligation "related to the previously agreed-upon evaluation of cardiovascular outcomes."

"We are working expeditiously with the FDA to finalize the review," said Michael Narachi, CEO of Orexigen. "We are encouraged by the high level of engagement with the FDA and are confident that we can reach agreement on the remaining postmarketing obligation."

Bupropion/naltrexone is also awaiting approval for obesity in Europe; the European Medicines Agency has been notoriously tough on obesity drugs of late, rejecting 2 that are approved in the United States, lorcaserin (Belviq, Eisai) and phentermine/topiramate (Qsymia, Vivus).

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