Diet drugs make second bid for FDA approval
Despite the latest rejections, two drug makers are resubmitting their products for a second review. Orexigen Therapeutics’ Contrave and Arena’s Lorcaserin are hoping to receive favourable decisions from the Food and Drug Administration.
Orexigen Therapeutic’s Contrave is a combination pill aimed at curbing appetite, mixing the antidepressant ingredient in Wellbutrin with the anti-smoking drug bupropion. The company’s results have been lackluster, with about 40 percent of patients taking Contrave losing 5% of their body weight. Those figures narrowly achieved FDA’s minimum requirements for an effective weight loss pill. But Contrave has also been plagued by the heart safety concerns associated with past diet pills. The FDA is requiring the company to conduct a 10,000-patient study of cardiovascular health. That study is slated for completion by 2014.
Meanwhile, Arena’s lorcaserin is the only first-of-a-kind diet drug. It uses a new type of ingredient to stimulate serotonin receptors in the brain linked with feelings of satiety. But Lorcaserin has faced the most severe safety questions from FDA, which rejected the drug in 2010 after raising concerns about cancerous tumors seen in rats who received the drug.
Early this year Arena submitted new information evaluating the link between its drug and cancer. The FDA is scheduled to make a new ruling on the drug by June 27.
Category: Pharmaceuticals
