WASHINGTON, Feb. 1 (UPI) -- The U.S. Food and Drug Administration has denied approval of the weight-loss drug Contrave, the third similar drug it has kept off the market in recent months.
Going against the recommendation of its own advisory committee, the FDA said the benefits of the drug were not sufficient to outweigh the potential risks and the potential for abuse, noting many patients receiving the drug had a slight increase in blood pressure and pulse rates, the Los Angeles Times reported Tuesday.
The drug's manufacturer, Orexigen Therapeutics Inc. of San Diego, said in a statement it had been told by the FDA it would need to conduct a large clinical trial to test for possible cardiovascular complications before the medication could be marketed.
Most analysts said such a long and expensive trial would be beyond the resources of Orexigen, which is concentrating exclusively on weight-control drugs and has no other products on the market, the Times reported.
In October, the FDA rejected two other proposed weight loss drugs; Qnexa because of concerns about heart problems and birth defects, and Lorqess, which appeared to cause tumor growth in animals.
