Oral naltrexone extended-release/bupropion extended-release (naltrexone 
ER/bupropion ER; Contrave(®), Mysimba(™)) is available as an adjunct to a 
reduced-calorie diet and increased physical activity in adults with an initial 
body mass index (BMI) of ≥ 30 kg/m(2) (i.e. obese) or a BMI of ≥ 27 kg/m(2) 
(i.e. overweight) in the presence of at least one bodyweight-related 
comorbidity, such as type 2 diabetes mellitus, hypertension or dyslipidaemia. In 
56-week phase III trials in these patient populations, oral naltrexone 
ER/bupropion ER 32/360 mg/day was significantly more effective than placebo with 
regard to percentage bodyweight reductions from baseline and the proportion of 
patients who achieved bodyweight reductions of ≥ 5 and ≥ 10%. Significantly 
greater improvements in several cardiometabolic risk factors were also observed 
with naltrexone ER/bupropion ER versus placebo, as well as greater improvements 
in glycated haemoglobin levels in obese or overweight adults with type 2 
diabetes. Naltrexone ER/bupropion ER was generally well tolerated in phase III 
trials, with nausea being the most common adverse event. Thus, naltrexone 
ER/bupropion ER 32/360 mg/day as an adjunct to a reduced-calorie diet and 
increased physical activity, is an effective and well tolerated option for 
chronic bodyweight management in obese adults or overweight adults with at least 
one bodyweight-related comorbidity.