ARTICLE | Clinical News

Qnexa phentermine/topiramate regulatory update

November 1, 2010 7:00 AM UTC

FDA did not request any new clinical trials in its complete response for obesity candidate Qnexa phentermine/topiramate. The company plans to submit a written response in 6 weeks. According to Vivus, the agency requested a comprehensive assessment of topiramate's and phentermine/topiramate's teratogenic potential, evidence that the elevation in heart rate associated with phentermine/topiramate does not increase the risk for major adverse cardiovascular events and a formal submission of the results from the completed Phase III SEQUEL (OB-305) extension study. In September, Vivus said Qnexa met the trial's co-primary endpoints of mean percentage weight loss from baseline and percentage of subjects achieving >5, 10 and 15% weight loss vs. placebo at 108 weeks (see BioCentury, Sept. 27). ...