Vivus shares fall as FDA poses questions on birth defect with obesity drug Qnexa
US drugmaker Vivus (Nasdaq: VVUS) announced last Friday that, at an end-of-review meeting with the Food and Drug Administration for the New Drug Application (NDA) for the firm’s obesity drug Qnexa (phentermine/topiramate), the regulator asked about an analysis of birth defects related to an ingredient - topiramate - in its drug. The news saw the company’s stock plunge 16% to $8.74.
Topiramate is the active ingredient of Johnson & Johnson’s migraine and epilepsy drug Topamax, and there have been reports of women who take topirmate for migraines having an increased risk of having a baby with cleft lip.
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