ARTICLE | Clinical News

Contrave regulatory update

December 13, 2010 8:00 AM UTC

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 13-7 that the benefit-risk profile of Orexigen's Contrave supports approval as a long-term treatment for obesity. Although panel members were disappointed in the level of weight loss seen in the four Phase III trials included in the NDA, they felt that Contrave satisfied the agency's criteria for approval. They also felt it was important to have additional pharmacotherapies for long-term treatment of obesity. Xenical orlistat from Roche (SIX:ROG; OTCQX:RHHBY, Basel, Switzerland) is the only drug approved in the U.S. for long-term treatment of obesity.

According to draft guidance for obesity candidates published by FDA in 2007, the placebo-adjusted weight loss must be 5% for those in the treatment arm of the study, or the proportion of patients who lose at least 5% of baseline body weight in the treatment group should be double the proportion in the placebo group. While Contrave missed the first benchmark in all 4 of the Phase III trials, it met the second in 3 of the trials. Pooled data from Orexigen's Phase III program showed that the low- and high-doses of Contrave produced placebo-adjusted mean weight loss of 3.7% and 4.2%, respectively. ...