Selincro: on-demand tablet for patients with alcohol dependence

Selincro (nalmefene) is indicated in combination with psychosocial support for the reduction of alcohol consumption in adults with alcohol dependence. It should only be used in those who have a high drinking risk at initial assessment and 2 weeks later, and who do not have physical withdrawal symptoms or require immediate detoxification.

Selincro (nalmefene) should be taken once daily as needed when the patient perceives a risk of drinking alcohol.
Selincro (nalmefene) should be taken once daily as needed when the patient perceives a risk of drinking alcohol.

PHARMACOLOGY

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

CLINICAL STUDIES

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

Safety profile

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

References:

  1. Selincro Summary of Product Characteristics, February 2013.
  2. van den Brink W et al. ESENSE 1 and ESENSE 2. Posters presented at 21st European Congress of Psychiatry, Nice, France, April 2013. 

View Selincro drug record

Further information: Lundbeck

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