— Most drugmakers now are focusing on medications that block brain signals associated with food craving and appetite. Vivus' Qnexa is one of a trio of drugs seeking FDA approval. The diet pill, which was initially rejected due to the risks of heart palpitations and other safety issues, is a combination of two older drugs.
It uses phentermine, the appetite suppressant. The other drug is topiramate, an anticonvulsant sold by Johnson & Johnson as Topamax. Topiramate is believed to make patients feel more satiated, though it's unclear exactly how. J&J initially studied Topamax alone as a weight loss treatment but concluded the psychiatric side effects, such as memory loss and difficulty concentrating, were too significant.
Still, on Wednesday, a panel of FDA doctors and other advisers voted 20-2 in favor of approving Vivus' Qnexa pill, which the drugmaker has resubmitted to the FDA for a second review.
The group touted the drug's benefits, which include weight loss of nearly 10 percent for most patients taking the drug over a year — the highest reduction reported with any recent diet pill. But panelists stressed that the drugmaker must be required to conduct a large, follow-up study of the pill's effects on the heart.
The FDA is expected to issue its decision on Qnexa by mid-April.
"The potential benefits of this medication seem to trump the side effects," said FDA panel member Dr. Kenneth Burman of the Washington Hospital Center in Washington DC. "But in truth, only time will tell."
Tammy Wade of McCalla, Ala., is confident that the diet pill works. She lost nearly 40 pounds, dropping down to 167 while in a two-year Qnexa study.
"I never lost that much weight on any of the programs I've tried," said Wade, who's done everything from Weight Watchers to work out with a personal trainer.
Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.