Orlando, FL 12/12/11 (StreetBeat) -- Vivus (Nasdaq: VVUS) said late yesterday there was an increased association between babies born with an oral cleft in mothers who took the drug in the company’s weight loss treatment while pregnant.Mothers who had taken the antiepileptic drug topiramate in the first trimester of pregnancy showed prevalence rate of 0.29% of babies born with oral clefts, according to Vivus’ retrospective study of medical claims data, while mothers who took the drug prior to pregnancy but not during pregnancy has a 0.16% prevalence.
Women with similar medical profiles but no topiramate exposure had a prevalence of 0.07% babies born with oral clefts.
Vivus’ Qnexa weight loss drug is a combination of phentermine and topiramate, and has shown statistically significant weight loss, glycemic control and improvement in cardiovascular risk factors in studies thus far.
Vivus resubmitted its new drug application for Qnexa in October with a contraindication for women of childbearing age, and is studying the impact of the drug in pregnant women and babies.
The company has been in a race to develop an FDA-approved obesity drug, with rivals Arena Pharmaceuticals (ARNA) and Orexigen (OREX).
Vivus shares are taking a hit today on the news that the ingredient in Qnexa is associated with oral cleft defects.
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