Following a full submission:
nalmefene 18mg film-coated tablets (Selincro®) are accepted for use within NHS Scotland.
Indication under review: the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), without physical withdrawal symptoms and who do not require immediate detoxification. Nalmefene should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption. Nalmefene should be initiated only in patients who continue to have a high DRL two weeks after initial assessment.
In a post hoc analysis of two pivotal phase III studies representing the licensed population, nalmefene was shown to significantly reduce alcohol intake compared with placebo, measured as a reduction in heavy drinking days and total alcohol consumption over a six month period.
|Drug Name:||nalmefene (Selincro)|
|SMC Drug ID:||917/13|
|Indication:||For the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), without physical withdrawal symptoms, and who do not require immediate detoxification.|
|Sub Category:||4.1 Hypnotics and axiolytics|
|Submission Type:||Full submission|
|Date Advice Published:||7 October 2013|