WASHINGTON, July 15 (Reuters) - The first potential U.S. prescription weight-loss pill in more than a decade could move closer to market on Thursday if it can overcome safety hurdles that have plagued diet drugs for years and led to tepid sales despite the growing number of obese Americans.
Vivus Inc is seeking Food and Drug Administration support to sell its drug, Qnexa, to adults to use once-a-day along with exercise and diet changes to slim down.
On Thursday, a FDA advisory panel will weigh Qnexa -- the first of three potential new diet drugs -- and decide whether the benefits of shedding pounds outweigh safety concerns such as the drug's effect on fetuses, mental health and heart rate.
The FDA will weigh the panel's recommendation before later making its final decision.
Although more than two-thirds of Americans are overweight or obese, weight-loss drugs have not gained much traction. Most only trim a few pounds but carry serious or unpleasant side effects such as heart risks or gas.
FDA staff have said the company's data clearly shows the drug works and largely meets the agency's new guidelines for obesity drugs issued in 2007.
Patients taking Qnexa saw between 3 and 9 percent weight loss over placebo depending on how much of the drug they took, the staff said. They also benefited from improved blood pressure, and better fats and sugar levels in the blood.
But first Vivus must convince FDA's panel of outside experts that it does not harbor significant safety issues that have sidelined past options.
Qnexa attempts to improve on the infamous "fen-phen" diet drug. It combines one of fen-phen's ingredients -- the appetite suppressant phentermine -- with the anti-seizure drug topiramate. Fen-phen's other ingredient, fenfluramine, was yanked in 1997 when serious heart valve problems emerged.
FDA staff earlier this week said they were particularly focused on five potential risks: the potential for congenital defects, psychiatric problems such as depression, memory loss and other cognitive issues, increased body acids, and higher heart rates.
"I think it's pretty well established that Qnexa has strong efficacy ... The real question will be how the members of the panel view those safety concerns against the efficacy benefits," Canaccord Adams analyst Adam Cutler told Reuters.
The agency plans to ask its panelists to weigh each area of concern before voting on whether to back the drug.
FDA officials usually follow their panelists' advice. A decision is expected by Oct. 28.
Diet pills already on the market include Abbott Laboratories' Meridia, which carries several heart-related risks, and Roche Holding AG's Xenical, which causes liver problems and uncontrolled bowel movements.
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