Lundbeck has announced plans to initiate three late-stage studies for the alcohol dependence drug nalmefene.

The Danish drugmaker says that earlier trials have documented nalmefene's ability to “significantly limit both the patient's average alcohol intake and the number of days with an intake above five units of alcohol”. Those studies have also shown that nalmefene, an opioid receptor antagonist which was developed by Finland’s BioTie Therapies Corp, is well-tolerated and safe.

Lundbeck is now launching three Phase III trials enrolling more than 1,800 patients randomised into receiving nalmefene and placebo respectively. The first data from the trials are expected in the first half of 2011.

The Valby-based firm said that unlike existing therapies, nalmefene is not aimed at keeping patients but rather removes the desire to drink more, “thereby controlling and limiting the intake of alcohol”. In addition, nalmefene is available as a tablet “to be taken only according to need, whereas existing pharmaceuticals must be taken continuously over a longer period of time”.

Lundbeck, which holds the rights to the compound outside North America, Mexico, Turkey and South Korea, quoted World Health Organisation figures which estimates that more than 76 million people worldwide suffer from alcohol abuse. Some 3-5% of Europe's population are believed to be alcoholics.