Nalmefene: a review of its use in the treatment of alcohol dependence.
Author(s): Keating GM.
Affiliation(s): Author information:
Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754,
Auckland, New Zealand. demail@springer.com
Publication date & source: 2013, CNS Drugs. , 27(9):761-72
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.
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