In a 13-to-7 vote yesterday, an FDA advisory panel recommended the approval of Orexigen Therapeutics’ anti-obesity drug Contrave, saying that the drug’s benefits outweighed its risks. The news comes after two weight-loss drugs — Qnexa from Vivus and lorcaserin from Arena Pharmaceuticals — were rejected by the FDA earlier this year. While only producing moderate weight-loss effects, Contrave has been associated with a rise in blood pressure and pulse rate. This will warrant another, larger clinical trial to specifically address the drug’s potential for increased risk of heart attack.
“The advisory committee’s recommendation for approving Contrave, a combination therapy of antidepressant bupropion and addiction-treating naltrexone, is welcome news,” says ACSH’s Dr. Josh Bloom.
“I suspect this recent approval may have something to do with the FDA’s realization that after pulling Meridia from the market and denying approval for Qnexa and lorcaserin, they are gradually depriving obese patients from any drug therapies,” adds ACSH's Dr. Gilbert Ross. “The only available drug therapy to counter obesity now is Xenical and its OTC form, Alli — and both cause troublesome side effects involving oily bowel movements. So this new panel verdict may be welcome news if the FDA agrees early next year.”