HealthDay News — A new weight-loss medication has been approved by the FDA as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
Contrave is a combination of two already-approved drugs, naltrexone and bupropion, in extended-release form. The medication is approved for use in people with a body mass index (BMI) of 30 or higher, reported the FDA in a news release.
Contrave is also sanctioned for people with a BMI of 27 or higher who also have at least one weight-related chronic health condition such as hypertension, dyslipidemia, or type 2 diabetes.
The safety and efficacy of the drug was determined in clinical trials involving 4,500 obese and overweight patients. Results showed that patients who took Contrave had an average weight loss of 4.1% more compared with patients who were assigned placebo.
Patients who are prescribed Contrave should be evaluated after 12 weeks to determine if the treatment has worked, advised the agency.
The drug’s label will have a boxed warning of the possibility of suicidal thoughts and behaviors associated with antidepressants. The medication may also cause seizures and should not be prescribed to patients with a seizure disorder, recommended the FDA.
Post-marketing studies, including evaluations of any cardiovascular risks and of the drug’s use among children have been ordered by the FDA.
Contrave is distributed by Takeda Pharmaceuticals, of Deerfield, Illinois.