Vivus Faces New Safety Issue
Vivus (NASDAQ: VVUS), the Mountain View, CA-based developer of an obesity drug, said today that U.S. regulators have asked the company about whether it could look for any connection between one of the key ingredients in its new drug and oral clefts in newborns. Vivus is seeking approval of a combination of phentermine and topiramate (Qnexa) for weight loss. Topiramate can be given to prevent migraine headaches, and there have been two published cases of oral clefts (sometimes called cleft lips or cleft palates) in babies born to women who took topiramate in the U.K., and four in the U.S., Vivus said. The company’s application for approval of Qnexa was turned down in October. Vivus, which says it saw no cases of oral clefts in women who got Qnexa in its trials, said it will continue to discuss ways to resubmit its application to the FDA.