Orexigen Therapeutics Inc. indicated today that the Food and Drug Administration (FDA) has, in effect, decided not to approve the company’s obesity drug, Contrave ® in spite of a federal advisory panel vote of 13-7 in favor of approval in December of 2010. The FDA is requiring the company to complete a lengthy and expensive pre-approval of cardiovascular risks. Previously, the FDA had rejected two other new compounds: one developed by Vivus Inc. (Qnexa®) and the other, lorcaserin, by Arena Pharmaceutical Inc. (Lorquess ®) The FDA also pressured Abbott Laboratories to take orlistat (Meridia®) off the market.
According to Morgan Downey, editor and publisher of the Downey Obesity Report, “The FDA has decided that the most significant threat to public health will not be treated by any drug. In the current environment, tap water could not be approved. This is the first time in the FDA’s history that it has decided to abandon a major public health challenge. No doubt the FDA will continue to regularly approve drugs which cause weight gain and to half-heartedly police dangerous and unproven dietary supplements claiming to achieve weight loss. These actions have driven both large pharmaceutical companies and small biotech companies out of obesity research and development. At this time, only Vivus Inc.’s Qnexa has a hope of meeting FDA’s approval.” The FDA has asked Vivus Inc. to explore databases to rule out birth malformations due to one of its elements.