FDA wants birth defect data from Vivus ($VVUS)

The FDA has asked Vivus ($VVUS) to assess the feasibility of analyzing existing healthcare databases to determine the incidence of  oral cleft in women who've taken topiramate for migraines. Vivus obesity drug candidate Qnexa is a combination of two existing drugs: topiramate and the appetite suppressant phentermine. When the FDA issued a complete response letter for Qnexa in October, it included a request for a plan to handle the risks Qnexa may present to women who are pregnant or may become pregnant.

In a release, Vivus noted that of the 15 women in clinical studies who'd given birth after taken the drug, none had offspring with birth defects. But there are six published reports of children with oral cleft born to women who've taken topiramate. In a release, Vivus noted its Qnexa resubmission will be decided once it reaches an agreement with the FDA on the feasibility assessment. "Left unanswered by Vivus is what happens if those existing healthcare databases cannot provide the new safety information requested by FDA," observes Adam Fuerestein of TheStreet. The company originally planned to resubmit Qnexa in the first half of this year.

Vivus is in a tight race with Orexigen and Arena Therapeutics to gain approval for a new obesity drug. It's a notoriously difficult development field littered with failures. So far Orexigen is in the lead; in December an expert panel voted 13 to 7 in favor of approving its drug Contrave.

- take a look at Vivus' release
- read the write-up from TheStreet