Nalmefene in the treatment of alcohol dependence in Europe – from regulatory approval to clinical use.

Sandra Helinski

Christoph von der Goltz, M.D., H. Lundbeck A/S, Denmark


In early 2013 the European Medicines Agency (EMA) approved nalmefene for reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level. Despite a long period (>10 years) of problem drinking, the vast majority of the alcohol-dependent patients included in the nalmefene clinical trials had not previously received any treatment for their condition, underlining the need for a new approach to treating these patients. The talk will give an overview of the path from regulatory approval of nalmefene to use in clinical practice.