EMA Committee Gives Green Light to Alcohol Abuse Drug

Caroline Cassels


December 14, 2012

An advisory committee to the European Medicines Agency (EMA) has recommended that nalmefene (Selincro, H. Lundbeck A/S), a drug for the reduction of alcohol consumption in adult patients with alcohol dependencies who have a high drinking risk level, who are without physical withdrawal symptoms, and who do not require immediate detoxification, be given marketing approval.

On Thursday, the Committee for Medicinal Products for Human Use announced that it had adopted a positive opinion and recommended the opioid receptor antagonist be granted marketing authorization.

Acute alcohol intake has been shown to result in mesolimbic dopamine release, which can provide positive reinforcement. Nalmefene is thought to counteract these reinforcement effects, thereby reducing alcohol consumption.

The most common side effects are "unspecific" and include nausea or dizziness; some patients have reported sleep-related events.

The committee also recommended that the drug be prescribed in conjunction with "continuous psychosocial support that focuses on treatment adherence and reducing alcohol consumption."

Further, it recommended that the drug only be prescribed to patients who continue to have a high drinking risk level 2 weeks after initial assessment.