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Lundbeck initiates phase III trial with nalmefene

H. Lundbeck A/S (Lundbeck) is continuing the development of nalmefene for the treatment of alcohol dependence as scheduled, initiating three phase III clinical trials with the compound.

Nalmefene builds on a novel principle of treating alcohol dependence. Unlike existing therapies, the treatment with nalmefene is not aimed at keeping the patients from drinking. Nalmefene instead removes the desire to drink more, thereby controlling and limiting the intake of alcohol. In addition, nalmefene distinguishes itself by being available as a tablet formulation to be taken only according to need, whereas existing pharmaceuticals must be taken continuously over a longer period of time.

A previous study 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. This means a sharp reduction in patients’ risk of developing diseases such as various cancers, cardiovascular diseases and cirrhosis of the liver. Previous trials have also shown nalmefene to be well-tolerated and safe.

Based on the earlier trials, Lundbeck is now launching three phase III trials enrolling more than 1,800 patients randomised into groups receiving nalmefene and placebo respectively. The first two trials, in which patients are treated over a period of six months, primarily aim to demonstrate the efficacy of nalmefene, whilst the objective of the last study, in which patients are treated for 12 months, is particularly to confirm that the compound is well-tolerated. The first data from the trials are expected in the first half of 2011.

“Nalmefene offers a rare opportunity for us to provide a new and more effective treatment of alcohol dependence, which causes major harm to millions of people worldwide,” says Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck.

Nalmefene is a so-called opioid receptor antagonist. The compound acts by blocking the mechanism in the brain that can cause a continuing and uncontrolled intake of alcohol. This helps to control and limit the intake.

Nalmefene was originally developed by BioTie Therapies Corp. of Finland. Lundbeck holds the global rights to the compound with the exception of North America, Mexico, Turkey and South Korea.

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