Vivus Weight-Loss Pill Approved -- Maybe?
MOUNTAIN VIEW, Calif. (TheStreet) -- U.S. regulators have apparently approved Vivus'(VVUS) weight-loss pill Qsymia on Tuesday, which means obese Americans now have a choice in prescription diet pills.
A story touting Qsymia's approval was published prematurely by USA Today earlier today. The story, since removed from the newspaper's web site, quotes Vivus executives and doctors about Qsymia and its approval. Clearly, the reporter wrote the story under embargo with Vivus' cooperation but was not supposed to publish until after an official announcement from FDA that the weight-loss pill had been approved.
Neither Vivus nor officials from the U.S. Food and Drug Administration have made made any official comment.
Vivus shares are down 1% to $28.30 in recent trading, which has been volatile throughout the day.
So, FDA has now reportedly approved two new medicines to treat obesity in the past three weeks, ending a 13-year drought. The first pill, Arena Pharmaceuticals'(ARNA) Belviq, was approved on June 27.
Approximately one-third of adult Americans are obese today, according to the Centers for Disease Control. Obesity is growing public health problem in the U.S., in part because people who carry unhealthy weight are at greater risk for heart disease, diabetes and other diseases.
Qsymia, formerly known as Qnexa, combines two currently approved drugs -- phentermine, a generic weight loss drug, and topiramate, used to treat epilepsy and migraines.
FDA reportedly approved Qsymia based on data from clinical trials showing the drug helps patients lose approximately 10% of their baseline weight after one year. Similarly, 60-75% of Qsymia-treated patients lost at least 5% of their body weight after one year.
Women who take Qsymia while pregnant are at risk for giving birth to children with birth defects. For this reason, FDA has reportedly placed warnings on Qsymia's label urging women to use birth control while taking the weight-loss drug.
Vivus will conduct a post-approval cardiovascular outcomes study of Qnexa in order to further demonstrate that long-term use of the drug doesn't increase the risk of heart-related side effects.
Qysmia reportedly received U.S. approval on its second attempt. FDA rejected the drug in 2010 due to safety concerns. A subsequent FDA advisory panel held in February voted 20-2 to recommend the drug's approval.