After running into a roadblock thrown up by regulators at the FDA, Vivus ($VVUS) says it has mapped out a possible route to gain a near-term approval for its obesity drug Qnexa--but the path leads to a much smaller market than it had hoped for. And in hopes of clearing the regulatory hurdle that is blocking its path to the mass market, the developer says that it has reached a basic agreement with the FDA on the design of a retrospective study to determine if one of the active ingredients in its diet drug poses a threat to pregnant women.
Mountain View, CA-based Vivus used its quarterly report to outline the regulatory update for Qnexa, noting that it reached an agreement with the FDA on resubmitting Qnexa for approval to market the drug to obese men and women who have passed their child-bearing years. Restricting the drug would satisfy the agency's safety concerns, but an older segment of the obesity market is a far cry from the blockbuster mass market that it has hoped it can reach. And Vivus added that it would make its decision on whether it would go ahead and pursue the much more limited approval after it comes up with a timeline on the retrospective study. A resubmission would require a six-month review process and an advisory panel meeting.
Regulators are concerned that one of the two ingredients in Qnexa, the anti-seizure drug topiramate, might trigger various birth defects--including cleft palates--in newborns. So Vivus hammered out the protocol on the retrospective study, with a plan to use existing databases to compare the experiences of newborns exposed to the drug and a control arm consisting of children who were exposed.
The resubmission for a limited approval is slated for the fourth quarter, and the news helped buoy Vivus shares. Vivus cut its quarterly loss to $9.9 million, down from $18.8 million in the first quarter of 2010.
- check out the Vivus release
- and here's the Reuters story