Nalmefene: A Review of Its Use in the Treatment of Alcohol Dependence

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Abstract

The opioid system modulator nalmefene (Selincro®) is approved in the EU for as-needed use to reduce alcohol consumption in alcohol-dependent adults with a high drinking risk level. This article reviews the efficacy and tolerability of as-needed oral nalmefene in the treatment of alcohol dependence, as well as summarizing its pharmacological properties. In two randomized, double-blind, multinational trials (ESENSE 1 and ESENSE 2), as-needed nalmefene significantly reduced the number of heavy drinking days (in both trials) and total alcohol consumption (in ESENSE 1) at month 6. In the randomized, double-blind, multinational SENSE trial, as-needed nalmefene significantly improved both of these endpoints at month 13, but not at month 6. As-needed nalmefene had a greater beneficial effect in the target population (i.e. alcohol-dependent patients with at least a high drinking risk level at screening and randomization), with post hoc analyses revealing significant reductions in both the number of heavy drinking days and total alcohol consumption at month 6 (in ESENSE 1 and ESENSE 2) and at month 13 (in SENSE). Oral nalmefene was generally well tolerated in patients with alcohol dependence, with the most commonly occurring adverse events including nausea, insomnia and dizziness. In conclusion, as-needed nalmefene provides an important new option for use in the treatment of alcohol dependence.

Nalmefene in alcohol dependence: a summary

First pharmacological therapy to be approved in the EU to reduce alcohol consumption in alcohol-dependent adults with a high drinking risk level

Nalmefene in alcohol dependence: a summary

As-needed use significantly reduced both the number of heavy drinking days and total alcohol consumption in alcohol-dependent patients with at least a high drinking risk level at screening and randomization (i.e. the target population)

Nalmefene in alcohol dependence: a summary

Generally well tolerated

Nalmefene in alcohol dependence: a summary

Has the potential to engage more patients in treatment

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