FDA Won’t Require Qsymia CV Outcome Trial

FDA has notified Vivus that it has removed the requirement for a cardiovascular outcome trial for its weight-management medication Qsymia (phentermine and topiramate extended-release capsules). An agency letter said that positive topline data from a postmarketing study evaluating the effect of Qsymia on 24-hour ambulatory blood pressure does not raise concerns about cardiovascular risk and further assessment through a dedicated outcome trial would not be additionally informative, a company statement says.

Vivus says Qsymia was approved by FDA in 2012 and is the leading non-injectable branded weight-loss medication in the U.S. for adults. It is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long-term in adults and pediatric patients aged 12 and older with obesity, and in adults with overweight in the presence of at least one weight-related comorbid condition.