H. Lundbeck A/S (Lundbeck) has announced that the European Commission granted marketing authorisation for Selincro® (nalmefene) for the reduction of alcohol consumption in adult patients with alcohol dependence.
“Selincro represents the first major innovation in the treatment of alcohol dependence in many years,” said Executive Vice President Anders Gersel Pedersen, Head of Research & Development at Lundbeck, and continued: “The approval of Selincro is exciting news for the many patients with alcohol dependence who otherwise may not seek treatment.”
Selincro is a unique dual-acting opioid system modulator,(1,2) and acts on the brain’s motivational system, which is dysregulated in patients with alcohol dependence.(3) Selincro is thought to reduce the reinforcing effects of alcohol, and thereby reduces the urge to drink alcohol.(4,5) Lundbeck will provide Selincro as part of a novel treatment concept that includes continuous psychosocial support focused on the reduction of alcohol consumption and treatment adherence. It has been developed for use on an as-needed basis, with one tablet taken each day when the patient feels a risk of drinking.
“For a large proportion of patients with alcohol dependence, reduction of alcohol consumption is a more acceptable and realistic treatment goal”, commented Professor Dr. Karl F. Mann, Head of the Department of Addictive Behaviour and Addiction Medicine at the Central Institute of Mental Health in Mannheim, Germany. “Offering this treatment option opens a new chapter in the treatment of alcohol dependence.”
The marketing authorisation of Selincro is based on the results of three pivotal, randomised, double-blind, placebo-controlled trials that evaluated the efficacy and safety of Selincro in approximately 2,000 alcohol dependent patients.
Selincro has been shown to be effective in reducing alcohol consumption in patients with high drinking risk level. Patients treated with Selincro showed a 40% reduction in total alcohol consumption within the first month, and after six months the alcohol intake was reduced by approximately 60%. This corresponds to an average reduction equal to nearly one bottle of wine per day. Data from the 1-year study suggested longer-term efficacy of Selincro beyond six months. Selincro is generally well tolerated and adverse events were mostly mild to moderate and transient.
The approval of Selincro applies to all 27 European Union (EU) member states. Subject to the completion of pricing and reimbursement discussions, Lundbeck expects to launch Selincro in its first markets in mid-2013.
References
- Michel et al. Meth Find Exp Clin Pharmacol 1985; 7: 175-177
- Hillemacher et al. Expert Opin. Investig. Drugs 2011; 20(8): 1073-1086Heinz et al. Addict Biol 2009; 14(1): 108-118
- Spanagel & Valentina. Curr Topics Behav Neurosci 2013; 13: 583–609
- Drobes et al. Alcohol Clin Exp Res 2004; 28(9): 1362-70
