July 16, 2010

FDA Advisors Reject New Obesity Pill

A Food and Drug Administration (FDA) panel has rejected an experimental anti-obesity medication produced by Vivus, Inc. due to the potential safety risks, according to various media reports Friday.

According to Matthew Perrone of the Associated Press, the FDA advisors "voted 10-6 against Vivus's Qnexa, citing uncertainty about the potential risks that could come with long-term use of the drug. The FDA will consider the panel's ruling and make its own decision on the drug in coming months."

"Panelists unanimously agreed the drug helps patients lose pounds, with most reporting more than 10 percent weight loss," Perrone continues. "But those benefits were outweighed by a slew of safety concerns that cropped up in company trials, including memory lapses, suicidal thoughts, heart palpitations and birth defects."

Panel chairperson Kenneth Burman of the Washington Hospital Center said that the side effects were "serious" and potentially "life-threatening," and that those dangers "must be weighed against a relatively modest weight loss."

Vivus CEO Leland Wilson said that the company was "disappointed" with the outcome, but told AFP that the California-based drug manufacturer was still optimistic that the medication--a mixture of the amphetamine phentermine and the anticonvulsant topiramate--would ultimately win FDA approval.

"While the final vote was close, and we are encouraged that the committee recognized the efficacy demonstrated in the Qnexa clinical trials, we will work closely with the FDA leading up to our October 28, 2010 (decision) date to address the labeling and safety questions raised during today's proceedings. We remain committed to patients living with obesity and weight-related disease," Wilson told AFP.

According to Perrone, some of the panelists voted against the drug only because they felt more study was needed about Qnexa's long-term effects.

"I don't think we have enough data to say whether these are serious issues or not," National Institutes of Health statistician Michael Prochan told Perrone. "I think if we had had longer follow-up I could have voted the other way."

"You got the sense that a lot of people had a little bit of hesitancy," added Eric Coleman, deputy director of the FDA's metabolism division, who was not a member of the advisory panel. "They weren't strongly against the drug but they had enough concerns to make them lean towards 'no.'"


On the Net: