According to a study published today in the Journal of the American Medical Association, babies born to women who took anti-epileptic drugs, including topiramate, didn't experience a significant increase in birth defects. That's good news for Vivus ($VVUS), which uses topiramate (sold as Topamax by J&J) as one of the two key ingredients in its experimental anti-obesity drug Qnexa. The other ingredient is the appetite suppressant phentermine.
Vivus got a complete response letter from the FDA last October. The agency wanted the developer to address several issues, including the birth defect risk topiramate would present to women who are pregnant or could become pregnant. No new trials were requested, and the developer is currently in the process of examining existing databases to determine whether taking topiramate during pregnancy could cause cleft palate in offspring.
Vivus, along with Orexigen and Arena Pharmaceuticals, were locked in a close race to gain approval for their respective obesity drugs. But all three developers were shot down by the FDA. Arena elected to disregard the agency's request for a 12-month rat study and is conducting a three-month trial instead to satisfy the FDA's concerns about evidence of cancer seen in research animals. Orexigen is still pondering its future as it decides whether to conduct a long and expensive study to prove the cardiovascular safety of its obesity treatment Contrave. Vivus is arguably in the best spot, with just an analysis of existing studies standing in the way of approval. The developer will keep its fingers crossed and hope that it can gather information the necessary data without having to conduct a new study of its own.
- read the report from Bloomberg