Vivus’ shares have dropped since last Wednesday’s meeting with the FDA. The side effects associated with their weight loss drug, Qnexa, have been a point of worry for the FDA (Food and Drug Administration) and they will have to respond to questions regarding the rate of such side effects.
On the bright side, Vivus will not have to complete further clinical trials. Specifically, the FDA want to know if it is possible to use existing data to find out how frequently women who use one of the drugs ingredients, topiramate for migraine, subsequently give birth to babies with cleft palates.
The drugs company that manufactures this ingredient as Topamax for migraine, warn that birth defects and low birth weights are a risk when the drug is taken by pregnant women. Vivus say that 15% of the women participating in their clinical trials took Qnexa and no birth defects were reported. Vivus will decide whether or not they will be able to carry out this analysis in order to get ready to apply once again for the approval of Qnexa.