Please login to the form below

Not currently logged in
Email:
Password:

Lundbeck finishes alcohol dependency trials

Lundbeck completes phase III trials for alcohol dependency drug nalmefene

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.

15th June 2011

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Complete HealthVizion

Complete HealthVizion is a global team of fresh thinkers who aspire to be better every day. We create life-changing medical...

Latest intelligence

What pharma marketers can learn from behavioural science
Pharma behavioural science and traditional emotional marketing create a powerful mix of techniques that have impact on real lives....
NEW EU DATA PROTECTION REGULATION POISED TO CHANGE DATA PRIVACY LANDSCAPE
NEW EU DATA PROTECTION REGULATION POISED TO CHANGE DATA PRIVACY LANDSCAPE The bold digital clock featured on the EUGDPR (EU General Data Protection Regulation)1 website indicates – to the second...
Health knowledge: Why is it so important?
Health knowledge plays an important role in population health, but by itself is rarely enough to prompt a change in the behaviours that cause the risks....

Infographics