The European Commission has confirmed the approval issued in December by the European Medicines Agency (EMA) for the drug nalmefene, named by Lundbeck as ‘Selincro’, and has authorized the marketing in the EU of this first treatment for the reduction of alcohol consumption in patients with alcohol dependence.
Specifically, this drug “offers a new therapeutic approach for the treatment of adults with alcohol dependence who have a high-risk level of consumption,” explains the company. Thus, in clinical trials on 2,000 patients, it has been shown that “it reduced alcohol consumption by 60% of the patients after six months of treatment” and by 40% at the end of the first month, they maintain.
Pending the completion of the talks on price and reimbursement, from Lundbeck they affirm that they hope to commercialize ‘Selincro’ “in mid-2013 in the first markets, and in 2014 in Spain”.
Currently, alcohol dependence is considered “as a public health problem with detrimental consequences at a physical, mental and social level”, they indicate. In Spain, it is estimated that there are 200,000 people who suffer from alcoholism.
Executive Vice President and Head of Research and Development at Lundbeck, Dr. Anders Gersel Pedersen, explains that this unique modulator of the dual-acting opioid system “acts on the reward circuitry of the brain, which is poorly regulated in patients with alcohol dependence. “. Thus, it follows that the drug “reduces the desire to drink alcohol,” he says.
However, the new therapeutic concept offered by Lundbeck “includes sustained psychosocial support focused on reducing alcohol consumption and adherence to treatment,” adds the expert. Added to this is the administration of one tablet a day when the patient feels there is a risk of drinking, although “it has been developed for use based on the patient’s needs,” he says.
For his part, the head of the Department of Addictive Behaviors and Addiction Medicine of the Central Institute of Mental Health in Mannheim (Germany), Dr. Karl F. Mann, assures that reducing alcohol consumption “is a more realistic and acceptable therapeutic objective “.