(dailyRx News) A U.S. Food and Drug Administration panel has approved investigational diet drug Qnexa designed to treat obesity in adults. The panel had previously rejected the weight loss drug in 2010 based on safety concerns.
Though approved by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee in a 20-2 vote, the FDA is not bound to accept the recommendation for approval.
Drugmaker Vivus Inc. expects that the FDA will complete its review of the drug by April 17. Qnexa, a daily oral drug, was developed to address weight loss, type 2 diabetes and obstructive sleep apnea.
It combines appetite suppressant phentermine with topiramate, an anti-seizure and migraine medication. Qnexa is designed to work by decreasing a patient's appetite and making users feel full.
"We are pleased with the panel's approval recommendation in support of the safety and efficacy of Qnexa," said Peter Tam, president of VIVUS.
"We look forward to working with the FDA as they complete their evaluation. Obesity is a serious medical condition, and we are committed to making Qnexa available and providing physicians with a new medical treatment option in their battle with this public health epidemic."
Though the panel approved the drug, members did voice concerns about cardiovascular problems and birth defects. Vivus has pledged to undertake a 4-year study involving more than 11,000 patients following approval of the drug to better assess cardiovascular risks in obese patients.
Next month the FDA plans to discuss the possibility of having all weight loss drug makers complete studies to assess heart risks.