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.
At the meeting, the FDA requested that Vivus assess the feasibility of analyzing existing health care databases to determine the historical incidence of oral cleft in offspring of women treated with topiramate for migraine prophylaxis (100mg).
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