Drugs

, Volume 75, Issue 11, pp 1269–1280 | Cite as

Naltrexone ER/Bupropion ER: A Review in Obesity Management

Adis Drug Evaluation

Abstract

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/m2 (i.e. obese) or a BMI of ≥27 kg/m2 (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.

Notes

Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the authors on the basis of scientific and editorial merit. Sarah Greig and Gillian Keating are salaried employees of Adis/Springer.

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Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  1. 1.SpringerAucklandNew Zealand

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