FDA Panel Supports Combination for Weight Loss

Dr. Allison Goldfine, section head of clinical research at the Joslin Diabetes Center, Boston, said that because of the epidemic of obesity, “I have a greater threshold for accepting the potential risk,” despite the uncertainty over the magnitude of that potential risk. She added that she was concerned about the use of the product in people with underlying coronary disease, and that there should be clear warnings about the use of the drug in certain patients, such as those with depression, the elderly and with a seizure history.

Also voting positively, Dr. Gardner said she was influenced by “the preponderance of existing experience” and by “the promise of definite studies and monitoring going forward.”

Dr. Jules Hirsch, physician-in-chief emeritus, in the Laboratory of Human Behavior and Metabolism, Rockefeller University, New York, voted no, citing “the very marginal efficacy of the drug barely meeting the [FDA] requirements and the lack of any information as to what the efficacy might be after the one year.” Based on past experience with other weight loss agents, he predicted that “efficacy will wane rather quickly” and that this would likely become another failed weight-loss drug.

Bupropion was approved for depression in 1985, for smoking cessation in 1997, and for seasonal affective disorder in 2006; a sustained-release formulation was approved in 1996. Naltrexone was approved for treating opioid addiction in 1984.

This is the first of three new weight-loss products recently reviewed by the panel to be recommended for approval. In October, sibutramine (Meridia) was taken off the U.S. market because of long-standing safety concerns over increases in pulse and blood pressure associated with treatment.

If approved, Orexigen plans to market the combination as Contrave. The FDA usually follows the recommendations of its advisory panels, outside experts who have been cleared of potential conflicts related to the product under review. In rare cases, a waiver is granted to a panel member, but not at this meeting. The FDA is expected to make a decision by Jan. 31, 2011.

The product has not been submitted for approval outside of the United States, according to Orexigen.