Lundbeck finishes alcohol dependency trials

Lundbeck has completed the final study in its phase III programme to evaluate nalmefene for the treatment of alcohol dependence.

Unlike existing therapies, treatment with nalmefene is not aimed at keeping patients from drinking, but instead it helps patients control and limit their intake of alcohol. In addition, nalmefene is available as a tablet to be taken when required, whereas existing drugs must be taken continuously over a longer period of time and are aimed at maintaining abstinence.

Lundbeck assessed a wide range of primary and secondary endpoints in its phase III programme, 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, though some were not statistically significant at every single milestone.

Overall, nalmefene reduced heavy drinking days and total alcohol consumption by more than 50 per cent compared to pre-treatment baseline. The effect was observed during the first month of treatment and was maintained throughout the study period in the three trials.

The most frequent side effects reported by patients were dizziness, insomnia and nausea. These were usually mild and transient in nature.

Lundbeck plans to file a marketing authorisation application (MAA) in Europe by the end of 2011.