Orexigen continues to seek approval for its fixed-combination of naltrexone on bupropion, Contrave.
The biggest loser was Orexigen, whose obesity drug Contrave was rejected by the FDA on Feb 1.
Orexigen still has a lot of work to do, and there is no assurance that Contrave will be approved.
But the FDA budged on the requirement that the trial prove Contrave does not cause any heart attacks at all.
The company now says Contrave could be approved as early as 2014.
At the end of the study, the FDA says Contrave patients should have at most 40% more heart attacks than those on placebo.
Last year, the FDA rejected three proposed weight-loss drugs, Qnexa, lorcaserin and Contrave because of safety concerns ranging from heart to psychiatric issues.
Other big winners included Orexigen, up 59% after another surprise recommendation, by a committee advising the Food and Drug Administration to approve its obesity drug, Contrave.
Contrave, but the agency went against its panel's advice and asked the company to conduct a long-term cardiovascular outcomes trial before the FDA would again consider the drug.
But this week an FDA advisory committee gave the thumbs up to a third drug, Contrave, meaning there could be a new tool on the horizon for battling obesity.
Unlike various predecessors, most of which fell by the wayside because of side effects, Contrave combines two older medications into one that experts hope will help push off the pounds -- safely.
Yesterday, Orexigen, which seemed to have abandoned its obesity drug Contrave after the Food and Drug Administration asked for a giant study to prove the medicine is safe, jumped back in the weight-loss game .
Instead, the FDA said that the drug could be approved at an interim look two years into the study if patients on Contrave have fewer than twice as many heart attacks as those on a placebo group.
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