Orexigen Therapeutics Inc. is hoping the Food and Drug Administration (FDA) will grant its request to speed up the review process for its obesity drug Contrave. The agency rejected the weight loss drug in February 2011, saying it needed data from a large-scale study on the long-term cardiovascular effects associated with the medication before approval would be granted.
Contrave is a combination of two medications already approved by the FDA – bupropion, which is the active ingredient in the antidepressant Wellbutrin, and the anti-addiction drug naltrexone. Contrave is designed to influence the hypothalamus in order to decrease food intake over an extended period of time.
Orexigen said it is expanding a clinical trial in hopes of getting results faster. Instead of 7,000 patients, the company plans to enroll about 9,000 patients through the end of the year. Orexigen says this will allow it to conduct an interim analysis of the study two months sooner than expected.
Orexigen is eager to break into the diet drug market. In June and July, the FDA approved the first weight loss drugs in 13 years – Vivus Inc.’s drug Qsymia and Arena Pharmaceuticals Inc.’s Belviq. Both drugs were initially rejected based on concerns over cancer and cardiovascular risks. The agency requested more data before approval was granted. Qsymia just became available in the United States, and Belviq will be available in 2013.