Nalmefene has antagonist activity at the μ and δ opioid receptors and partial agonist activity at the κ opiod receptor. It is thought to reduce alcohol consumption by modulating cortico-mesolimbic functions, thus reducing the positive reinforcing effects of alcohol and the urge to drink.1
The efficacy and safety of nalmefene in patients with alochol dependence were assessed in two six-month randomised double-blind trials (ESENSE 1 and ESENSE 2).1,2
Investigators recruited patients with alcohol dependence, as defined in the DSM-IV. Patients with significant physical withdrawal symptoms or with a history of delirium tremens, hallucinations, seizures, significant psychiatric co-morbidity or hepatic dysfunction were excluded.1
One or two weeks after initial assessment, patients were randomised to receive nalmefene 18mg once daily as needed (when the patient perceived a risk of drinking) or placebo, both in addition to psychosocial support. The co-primary efficacy endpoints were change from baseline to month six in the number of monthly heavy drinking days and in daily total alcohol consumption.1
In both studies, subgroup analysis of patients with a high or very high drinking risk at randomisation (alcohol consumption >60g/day for men and >40g/day for women) showed a significant reduction in monthly heavy drinking days and daily total alcohol consumption in favour of nalmefene at month 1, which was maintained at month 6. The proportion of responders was greater in the nalmefene groups than in the placebo groups.1,2
The most common adverse reactions were nausea, dizziness, insomnia and headache. The majority of these reactions were mild or moderate and transient, generally associated with treatment initiation.1
- Selincro Summary of Product Characteristics, February 2013.
- van den Brink W et al. ESENSE 1 and ESENSE 2. Posters presented at 21st European Congress of Psychiatry, Nice, France, April 2013.
Further information: Lundbeck