Contrave, Newest Weight-Loss Option: FAQ

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 pressurehigh 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 andstroke 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?

Absolutely, doctors agree. “If you try to use it in isolation, that patient is not going to have success,” says Bipan Chand, MD. He’s the director of the Loyola University Medical Center’s Center for Metabolic Surgery and Bariatric Care.

The ideal patient, Chand says, is one who will look at their diet, make healthier choices, and get regular exercise, along with taking the medicine.

The drug will help with controlling how much someone eats, Foreyt agrees, ”but we still have to watch what we eat and exercise regularly.”

In clinical trials that included obese and overweight men and women, everyone received instructions on eating a reduced-calorie diet and getting regular exercise.

How much weight do people on this drug lose?

The amount varies, but on average, people lose 5% to 10% of their starting weight, according to clinical trials and experts.

In one 56-week study looking at Contrave combined with health habit changes, those on the drug lost more than 9% of their starting weight, while those onplacebo lost just 5%.

So a 200-pound person losing 10% would end up at 180 pounds, perhaps moving from the obese to the overweight range, or the overweight to the healthy weight range.

In clinical trials that studied more than 4,500 people, the drug helped people keep off weight for up to a year, the length of the studies, according to Orexigen. On average, those who took Contrave for 6 months and combined it with a weight-management program lost 25 pounds, the company says in a statement. Those who were on placebo and the weight-management program averaged a 17-pound loss.

According to the FDA, people without diabetes who were in one of the clinical trials and took Contrave had an average weight loss, at the 1-year mark, of 4.1% over those who took the placebo pill.

In another study of those with type 2 diabetes, those on the drug lost 2% more than those on placebo.

In approving Contrave, the FDA says that those using it at the maintenance dose ”should be evaluated after 12 weeks to determine if the treatment is working.” If the weight loss at that point is not at least 5% of starting weight, the drug should be stopped, according to the FDA, as it is not likely to work adequately and long-term for the patient.