Qnexa, an experimental diet pill one step closer to FDA approval

GlobalPost

Qnexa, a diet drug previously rejected by the Food and Drug Administration over safety concerns, should be approved, an advisory panel has said.

The panel of non-FDA physicians voted 20-2 in favor of the prescription anti-obesity pill made by Vivus Inc., the Associated Press reported.

The vote amounts to a recommendation that the FDA approve the drug, according to the Wall Street Journal, although the FDA isn't required to follow the advice of its panels. The FDA is expected to make a final decision by April 17.

The panel ultimately backed the drug due to its impressive weight loss results — most trial patients reported nearly 10 percent weight loss, the AP reported.

"The benefits of that degree of weight loss have been clear and unambiguous," the LA Times quoted Dr. Stephen Smith, scientific director at the Translational Research Institute in Orlando, Fla., who was not involved in the vote, as saying.

The committee's vote, he said, "recognizes that doing nothing in obesity has it consequences."

The paper points out that more than 35 percent of American adults are obese and another third are overweight. 

However the panel stress the importance of confirming the drug's safety — particularly its effects the heart — by tracking patients in a large, follow-up study.

According to the WSJ:

"The development of obesity compounds has been a tough area for companies since the fen-phen drug combination was taken off the US market in 1997 after one of the medication's components was linked to heart-valve damage. Abbott Laboratories removed its weight-loss drug Meridia from the US market in 2010 amid concerns about the drug's risk of side effects like heart attack and stroke." 

After the 2010 FDA rejection, Vivus had resubmitted Qnexa — which combines low doses of two older drugs, the anticonvulsant topiramate and the appetite suppressant phentermine — for FDA approval last week.

(GlobalPost reports: Experimental diet pill Qnexa to be reviewed by the FDA, again)

If approved, Qnexa would be the first prescription diet drug to reach the market since 1999, the LA Times wrote. 

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