ARTICLE | Financial News

Vivus under siege after FORTRESS analysis

December 23, 2011 1:35 AM UTC

Vivus Inc. (NASDAQ:VVUS) fell $1.72 (17%) to $8.68 on Thursday after reporting data from the FORTRESS study showing that topiramate -- a component of the company's obesity product Qnexa -- is associated with a higher prevalence of oral clefts in infants whose mothers received the compound during pregnancy. FDA is reviewing a resubmitted NDA for Qnexa, a low-dose combination of phentermine and topiramate, to treat obesity with a proposed label that that would contraindicate use of the drug in women of childbearing potential. The PDUFA date is April 17 (see BioCentury Extra, Dec. 21). ...