July 13th 2010
(VVUS) FDA to Review Vivus Drug
The US Food and Drug Administration (FDA) recently posted briefing documents on its website ahead of the review of Vivus’ (VVUS) obesity drug Qnexa by the FDA’s Endocrinologic & Metabolic Drugs Advisory Committee. While the FDA said that all three doses of Qnexa were efficacious for weight loss, the agency has raised questions regarding certain safety issues.
The FDA has highlighted five areas which will be discussed by the panel. These include psychiatric-related and cognitive-related adverse events, metabolic acidosis, cardiovascular events and the effect of the drug on pregnant women. We believe the main focus will be on increased adverse event reports of depression, anxiety, and sleep disorders and the potential clinical significance of the increase in heart rate. The advisory panel will be meeting on Jul 15 to discuss these issues.
Qnexa, Vivus’ lead pipeline candidate, is a proprietary oral drug candidate that combines two previously approved products, topiramate and phentermine, to employ a dual mechanism to treat obesity. Qnexa