SOURCE: Sept. 10, 2014, U.S. Food and Drug Administration, news release; Sept. 11, 2014, The New York Times
THURSDAY, Sept. 11, 2014 (HealthDay News) -- The U.S. Food and Drug Administration's approval of a new weight-loss drug on Wednesday marks the third time the agency has given its blessing to a new diet medication since 2012.
Called Contrave, the medicine is a combination of two approved drugs: naltrexone, which treats alcohol and drug addiction, and bupropion, which treats depression and seasonal affective disorder and is used to help smokers quit.
The agency said in a news release that Contrave can be used by obese adults and by overweight adults who have at least one other weight-related condition or illness, such as high blood pressure or type 2 diabetes.
According to the U.S. Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese, the FDA said in its news release.
"Obesity continues to be a major public health concern," said Dr. Jean-Marc Guettier, director of the division of metabolism and endocrinology products in the FDA's Center for Drug Evaluation and Research. "When used as directed in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, Contrave provides another treatment option for chronic weight management."
Two years ago, the FDA approved two other prescription obesity drugs, the first such drugs endorsed in more than a decade. But those two drugs -- Vivus's Qsymia and Belviq, made by Arena Pharmaceuticals and Eisai -- haven't sold well, The New York Times reported Thursday.
Disappointing sales may reflect the common belief that obesity is a problem of willpower, not a medical condition that requires pharmaceutical treatment, experts told the newspaper.
Contrave was developed for people unable to lose weight through diet and exercise alone who aren't ready for weight-loss surgery, according to the newspaper.
The drug's approval was based on the results of multiple trials involving 4,500 people. One trial found that 42 percent of people who took Contrave lost 5 percent of their body weight, compared to 17 percent who took a placebo. A second trial found 36 percent of people with type 2 diabetes who took Contrave lost 5 percent of their body weight, while only 18 percent of those on a placebo did.
Because Contrave contains bupropion, the label will include a boxed warning about the increased risk of suicidal thoughts and behaviors associated with antidepressants.
Contrave can also increase blood pressure, and should not be used in people with uncontrolled high blood pressure, according to the FDA. It can also cause seizures, and should not be used by those with seizure disorders. If it does not work after 12 weeks, the patient should stop taking it, the agency said.
Contrave's maker, Orexigen Therapeutics of La Jolla, Calif., must also conduct additional safety trials that will look at possible heart risks and safety of use in children and teens, the FDA said.
The U.S. National Library of Medicine has more about obesity and health risks.