Abstract
The opioid system modulator nalmefene (Selincro®) is the first pharmacological therapy to be approved in the EU to reduce alcohol consumption in adults with alcohol dependence and a high drinking risk level. In the target population (i.e. alcohol-dependent patients with at least a high drinking risk level at screening and randomization), as-needed oral nalmefene 18 mg reduced both the number of heavy drinking days and total alcohol consumption to a significantly greater extent than placebo at 6 and 13 months. Oral nalmefene was generally well tolerated in patients with alcohol dependence. Thus, as-needed nalmefene provides an important new option for use in the treatment of alcohol dependence.
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