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.
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.