Naltrexone and bupropion prolonged-release tablets (Mysimba by Orexigen Therapeutics Ireland Limited), is a new treatment option for weight management as an adjunct to a reduced calorie diet and increased physical activity. It was approved in the EU in March 2015 and is indicated for use in adults with a body mass index (BMI) >/= 30 (obesity), or adults with a BMI of >/= 27 (overweight) who have at least one weight related condition such as controlled hypertension. The EMA approval was based the results of four phase 3, multicentre, double-blind, placebo-controlled clinical trials in 4,536 obese and overweight adults who were treated for one year. The full review considers the evidence base in more detail and suggests that when used, alongside a healthy diet and exercise regimen, treatment with Mysimba should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight.
LMEN Review: Naltrexone and bupropion for weight management in adults (June 2015)