LOS ANGELES - Ignoring the recommendation of its own advisory committee, the Food and Drug Administration last week declined to approve the weight-loss drug Contrave, the third such drug the agency has kept off the market in recent months.
The agency concluded that the benefits of the drug - about 50 percent of patients were able to lose 5 percent of their body weight in clinical trials, compared to 10 percent of those receiving placebos - were not sufficient to outweigh the potential risks and the potential for abuse. Many patients receiving the drug had a slight increase in blood pressure and pulse rates.
The FDA notified the drug's manufacturer, Orexigen Therapeutics Inc., that it would have to conduct a large clinical trial of the drug to test for possible cardiovascular complications in the elderly and the obese before the medication could be marketed, according to a statement released by the company.
Such a trial would probably take three to five years and cost as much as $200 million. Most analysts believe that such a trial is probably beyond the resources of Orexigen, which is focused solely on the development of anti-obesity drugs and has no other products on the market.
Contrave is a combination of two drugs already on the market: naltrexone, a drug used to combat alcohol and drug addiction, and bupropion, an antidepressant better known by the brand name Wellbutrin. Market analysts had predicted that, if approved, Contrave could have yearly sales of $1.2 billion by 2018.
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Last October, the FDA rejected the proposed weight-loss drug Qnexa because of concerns about heart problems and birth defects. That same month, the agency rejected another experimental diet drug called Lorqess that appeared to cause tumor growth in animals. Also in October, the weight-loss drug Meridia was pulled from the market due to concerns that it boosted the rate of heart attacks and strokes.
