The FDA first rejected the drug combination in February 2011, asking the company to conduct a cardiovascular-outcomes trial because of concerns about the CV safety profile of bupropion/naltrexone when used long-term in a population of overweight and obese subjects….
The Food and Drug Administration has approved the latest prescription diet pill, Contrave, which is a combination of two previously FDA-approved drugs that treat addiction and depression. Orexigen Therapeutics subsequently began the 8,900-patient Light Study and, following encouraging interim safety and outcomes data from this trial, the company resubmitted the US new drug application at the end of last year.
In June of this year, the company announced the FDA was extending, by 3 months, its review of bupropion/naltrexone.
Now the agency appears at least partially satisfied. However, the approval comes with a requirement for several postmarketing studies, including one further evaluating the cardiovascular risks of the drug.
In addition, the drug comes with a boxed warning to alert health professionals and consumers about the risk for suicidal thoughts associated with bupropion and serious neuropsychiatric events associated with bupropion’s use in tobacco-cessation therapy.
Contrave helped patients lose more weight compared to a placebo in clinical trials involving 4,500 obese and overweight people.
With diet and exercise, the drug is approved for adults with a body mass index of 27 or greater, as long as they also suffer from at least one other weight-related condition like high blood pressure, type 2 diabetes or high cholesterol, the FDA said. Persons with a BMI of 30 or above can be prescribed the drug without consideration of compounding conditions.
In people with diabetes evaluated in a second trial, those patients lost an average of 2 percent more weight compared to the placebo. And 36 percent of people taking Contrave lost at least 5 percent of their body weight compared to 18 percent of people taking a placebo.
But like a lot of other prescription diet pills, it is accompanied by warnings of serious risks and side effects.
The extended release form of two component drugs — naltrexone, which treats alcohol and opiate addiction, and bupropion, which treats depression and seasonal effective disorders, and is used to help smokers quit — are combined in Contrave.
The approval of bupropion/naltrexone brings to four the number of obesity drugs now available in the United States. In addition, the approval comes on the day before an FDA advisory committee is to discuss whether to recommend approval of another potential obesity treatment, the glucagonlike peptide-1 (GLP-1) agonist liraglutide (Victoza, Novo Nordisk), which is already approved for the treatment of type 2 diabetes.
- 36 percent of people taking Contrave lost at least 5 percent of their body weight compared to 18 percent of people taking a placebo
- Contrave comes with a boxed warning about the risk for suicidal thoughts associated with bupropion and serious neuropsychiatric events
- The extended release form consist of naltrexone, which treats alcohol and opiate addiction, and bupropion, which treats depression and stop smoking products.
FDA Announcement Sept 11, 2014