Qnexa Complete Response Letter Seeks Fetal, Cardiovascular Assurance

The FDA has handed Vivus a complete response on its obesity candidate Qnexa, requesting new analyses to examine potential cardiovascular and pregnancy risks. No additional studies of Qnexa (phentermine/topiramate) are required and Vivus plans to submit its response within six weeks, CEO Leland Wilson said. The company will use analyses of existing nonclinical and clinical data to assess topiramate for potential risks to developing embryos. It also will provide a plan for evaluating and mitigating the potential teratogenic risks of phentermine/topiramate in women who may become pregnant.
Drug Industry Daily