Advice

in the absence of a submission from the holder of the marketing authorisation:

naltrexone / bupropion (Mysimba®) is not recommended for use within NHSScotland.

Indication under review: As an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of
• ≥ 30 kg/m² (obese), or
• ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension)

The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.

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Medicine details

Medicine name:
naltrexone bupropion (Mysimba)
SMC ID:
SMC2086
Indication:
As an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of • ≥ 30 kg/m² (obese), or • ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension)
Pharmaceutical company
Orexigen Therapeutics Ireland Limited (1)
Submission type
Non submission
Status
Not recommended
Date advice published
07 May 2018