Vivus’ miracle diet pill hits road block with the FDA

The Food and Drug Administration (FDA) has rejected an experimental diet pill called Qnexa, which had been touted by many experts as a miracle weight-loss drug.

Vivus, the company behind Qnexa, says it plans to answer the FDA’s questions and believe sufficient data exist to address the questions and no additional studies are required.

In July, an FDA advisory panel had voted against Qnexa, a combination of low doses of two approved drugs, topiramate and phentermine.

Though the FDA has asked for a detailed assessment of the teratogenic potential of Qnexa and one of its active ingredients – topiramate – plus a strategy for evaluating and mitigating that potential risk in women of childbearing potential, in addition to evidence that the drug does not increase the risk for major adverse cardiovascular events, regulators did not call for additional clinical trials.

With rates of obesity and diabetes rising around the world, health experts say new weight-loss drugs are needed, yet the drug class has a history of serious safety concerns.

Getting drugs approved to treat obesity has been a challenge this year. Last week, the FDA denied to approve Lorcaserin made by also California-based Arena Pharmaceuticals, after tests determined it caused cancerous tumours in laboratory rats. Also in October, FDA advised Abbott Laboratories to withdraw its drug Meridia due to concerns over its safety. A study revealed that the drug increased the possibility of strokes and heart attacks.