By Michael Fitzhugh
Vivus (NASDAQ:VVUS) says its efforts to negotiate a pathway to approval for its experimental diet drug, Qnexa, are moving ahead and that the company could submit new data to support the drug's approval for limited use by the end of the year.
The new application could constrain use of Qnexa to women unable to become pregnant and men in an effort to address the U.S. Food and Drug Administration's concerns that the drug could pose a risk of birth defects if used by women during pregnancy.
The FDA refused to approve Qnexa in October 2010 over worries about the potential for the combination drug's components—phentermine and topiramate—to disturb fetal development or cause birth defects. But it left the door open to future approval on the condition that Vivus submit further data and a detailed plan for evaluating and mitigating risks in women who might become pregnant.
In a January meeting, the FDA made an additional request that the company consider a study using healthcare databases to see if children born to women taking topiramate during pregnancy experienced a higher rate of birth defects. The Mountain View, California-based company has now revealed that in April, it reached a general agreement with the FDA on the design, primary endpoints, and eligibility criteria for such a study.
With positive results, the FDA could approve Qnexa within as little as 6 months following the resubmission of Vivus' new application. Getting the drug approved would be a coup for Vivus, since it would be the only one of three obesity drugs rebuffed by the FDA in the last year to find a way forward. But given the typical market for diet pills, which often includes many women of childbearing age, approval would likely be a small, and not particularly rewarding, victory for Vivus.