Sept. 11, 2014 -- The FDA's approval on Wednesday of a new prescription weight-loss pill offers yet another option for the more than one-third of American adults who are obese. Called Contrave, the new drug is the third prescription weight-loss drug to be approved by the FDA since 2012. It's also approved for those not obese but overweight with risk factors such as high blood pressure, high cholesterol, or diabetes.
Contrave joins Qsymia (phentermine and topiramate) and Belviq (lorcaserin). Both were approved in 2012.
Contrave combines two drugs already on the market: bupropion (Wellbutrin), an antidepressant, and naltrexone, an anti-addiction drug. Because it contains bupropion, the new drug will have a boxed warning to alert doctors and patients to the increased risk of suicidal thoughts that are linked with antidepressants.
Weight loss experts say all three drugs work in similar ways, but they welcome Contrave as yet another option, especially since not all weight loss drugs work the same for everyone.
The FDA approval came after the agency looked at new information it requested from the drug's maker in 2011 to be sure the drug was safe for the heart. Even so, the approval came with a requirement to do another study about the drug's effect on the heart.
Here’s what else to know about the new drug.
How does Contrave work?
''It takes away hunger and the cravings for food," says John Foreyt, PhD, professor of medicine and director of the Behavioral Medicine Research Center at Baylor College of Medicine, Houston. He was a researcher on a clinical trial studying Contrave. He does not have financial ties to Orexigen, the drug's maker, or to Takeda Pharmaceuticals, which plans to market the new drug.
How the combination works for weight loss is not entirely understood, even by experts. The bupropion helps lessen appetite, says William Troy Donahoo, MD, an endocrinologist and weight loss specialist at Kaiser Permanente, Denver. The naltrexone, he says, probably works by blocking certain receptors in the brain and curbing cravings.
Who is eligible to take it?
The drug, a daily pill, is approved for use in adults with a body mass index or BMI of 30 (obese), or a BMI of 27 (overweight) with conditions that raise heart and stroke risks, such as high blood pressure, cholesterol, or type 2 diabetes.
A 5-foot-9-inch person who weighs 183 pounds has a BMI of 27. At 203 pounds, his or her BMI is 30.
The drug should not be given to anyone with a seizure disorder, pregnant women or those trying to get pregnant, or anyone with an eating disorder, among others, according to the FDA.
Is the new drug meant to be used in combination with diet and exercise?
source : Contrave, Newest Weight Loss Option: FAQ