Lundbeck has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for nalmefene (Selincro™) intended for the treatment of alcohol dependence. Nalmefene is a small molecule distinct opioid system modulator that inhibits the reward pathway in the brain that reinforces the desire and craving for alcohol and other addictive substances, thus removing a person's desire to continue to drink.

Three phase III clinical studies in Europe have compared nalmefene (18 mg tablet as needed, orally) with placebo in approximately 2000 individuals with alcohol dependence, who also received a brief medical compliance programme focusing on motivation and adherence. Two of the three trials (ESENSE1 and ESENSE2), in which individuals were treated over 6 months, were primarily aimed at demonstrating efficacy, whilst the third study (SENSE), in which individuals were treated for 12 months, was primarily conducted to confirm safety and tolerability. A wide range of primary and secondary endpoints were evaluated including: number of heavy drinking days per month, total alcohol consumption, proportion of responders based on drinking measures, alcohol dependence symptoms and clinical status, liver function and other laboratory tests, pharmaco-economic outcomes and treatment discontinuation effects. All assessments were consistently in favour of nalmefene compared to placebo, and overall, nalmefene reduced heavy drinking days and total alcohol consumption by more than 50% compared to pre-treatment baseline. Furthermore, data from the 12-month safety study (SENSE) confirmed that the treatment effect of nalmefene was maintained after 1 year of treatment. The most frequent adverse events in patients taking nalmefene were dizziness, insomnia and nausea.