Vivus gains after FDA's Qnexa queries
Vivus Inc. (NASDAQ:VVUS) gained $1.62 (26%) to $7.75 on Friday after FDA did not request any new clinical trials in its complete response letter for obesity candidate Qnexa phentermine/topiramate. The company plans to submit a written response in six 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 Qnexa 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 greater than 5, 10 and 15% weight loss vs. placebo at 108 weeks.
In July, an FDA advisory committee voted 10-6 that the benefit-risk profile for Vivus' Qnexa phentermine/topiramate did not support approval for obesity. The panel agreed that Vivus demonstrated efficacy of Qnexa vs. placebo, but did not feel that Qnexa's safety was well characterized. ...