VIVUS Confident Though FDA Panel Rejects Qnexa

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An FDA Advisory panel reviewing safety data on three diet pills has issued its first verdict on Vivus Inc’s Qnexa – No. The panel voted 6 to 10 against a question that asked whether the panel believed the “overall risk-benefit assessment of Qnexa is favorable to support approval.”

The Endocrinologic and Metabolic Drugs Advisory Committee said that Qnexa resulted in “significant” weight loss, but raised questions about the drug’s long-term side effects, which included birth defects, depression, memory and attention lapses, and an increase in heart rate in some patients. Many panel members said they wanted to see more safety data before approving the drug rather than facing potential consequences afterward.

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Vivus CEO Leland Wilson said in a statement today that the company is “disappointed with the Advisory Committee’s vote” but is “encouraged that the Committee recognized the efficacy demonstrated in the Qnexa clinical trials.” He states that the company plans to work with the FDA to address the labeling and safety questions raised during the proceedings.

Qnexa is a once-daily controlled-release drug that combines phentermine, a stimulant that reduces the appetite, and topiramate, a drug which increases the sense of satiety (feeling full). In clinical studies, severely obese people lost an average of 14.7% of their body weight, compared with 2.5% on a placebo.

The FDA is expected to make a final ruling on Qnexa on October 28, 2010. The agency usually follows its panel recommendations but isn't required to. However, they often considers close votes a split decision. Eric Colman, FDA’s deputy director of its metabolic and endocrinology products division said, “"They weren't strongly against the drug but had lingering concerns.”

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