Ignoring the recommendation of its own advisory committee, the Food and Drug Administration on Tuesday 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% of patients were able to lose 5% of their body weight in clinical trials, compared with 10% 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. of San Diego, 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 think 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. The company's stock fell 73% to close at $2.50 in Nasdaq trading Tuesday after the FDA announcement.