FDA approval of a weight-loss drug? Fat Chance

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In a surprise ruling, the FDA decided yesterday to reject the weight-loss drug Contrave even though an advisory panel ruled 13-to-7 to recommend its approval in December. Developed by Orexigen Therapeutics Inc., Contrave was shown to reduce body weight by 5 percent or more in at least 35 percent of patients, but the agency dismissed the drug’s potential benefits after research revealed it caused a slight increase in blood pressure and pulse rates compared to placebo. Though the advisory panel voted to approve the drug on the stipulation that a long-term post-market study of Contrave’s heart risks would be completed, the FDA is requesting a clinical trial to resolve heart safety concerns before approval.

Disappointed with the FDA’s ruling, ACSH's Dr. Gilbert Ross points out that “thirteen experts on the advisory panel thought that Contrave warranted approval. As did I. This is the third setback for weight-loss drugs after the agency already rejected Vivus Inc.’s Qnexa and Arena Pharmaceuticals Inc.’s lorcaserin last year, and Meridia was pulled too. Now there are no effective weight-loss drugs available, except for the difficult-to-tolerate orlistat.”

ACSH's Dr. Elizabeth Whelan thinks the recent turn of events just goes to show that “drug makers trying to fight obesity with a pill have been thwarted by an excess of precaution at the FDA.”