Lundbeck booze pill for EU
pharmafile | March 1, 2013 | News story | Sales and Marketing | Lundbeck, alcohol, selincro
Lundbeck’s novel pill Selincro has been given European marketing authorisation to help patients with a drink problem to cut down.
Selincro (nalmefene) reduced alcohol consumption by nearly two thirds after six months in patients who are high-risk drinkers.
The European Commission decision is based on three randomised, double-blind, placebo-controlled trials in 2,000 alcohol-dependent patients.
Those taking the drug showed a 40% drop in total consumption within the first month and approximately 60% by six months – an average reduction equal to nearly one bottle of wine per day.
The dual-acting opioid system modulator acts on the brain’s motivational system and is thought to reduce the positive effects of alcohol – therefore reducing the urge to drink.
It will only be given to patients who continue to have a high drinking risk level two weeks after an initial assessment, and has been developed for use on an ‘as-needed’ basis.
Patients take one tablet a day, preferably an hour or two prior to when they feel they might want a drink.
“For a large proportion of patients with alcohol dependence, reduction of alcohol consumption is a more acceptable and realistic treatment goal,” explained Professor Dr Karl Mann, head of the Department of Addictive Behavior and Addiction Medicine at the Central Institute of Mental Health in Mannheim, Germany.
The manufacturer argues that there is a significant unmet need because alcohol dependence is under diagnosed and under treated.
In Europe, Lundbeck suggests, 14 million patients are dependent on alcohol yet more than 90% of them do not receive treatment at present.
“Selincro represents the first major innovation in the treatment of alcohol dependence in many years,” said Anders Gersel Pedersen, head of R&D.
Lundbeck says the trials also suggested Selincro’s efficacy lasted beyond six months and it was generally well tolerated with mild to moderate adverse effects.
Alcohol abuse is a major headache for governments, leading to crime and antisocial behaviour as well as ill-health through medical complications such as liver disease.
Alcohol dependence is a brain disease, with the level of consumption strongly correlated with the risk for long-term morbidity and mortality.
In the UK, the Department of Health warned last month that many people were unaware they were drinking at harmful levels.
Selincro will form part of a regime that also includes support focused on the reduction of consumption and adherence to treatment.
Lundbeck expects to launch it in some European countries in the summer “subject to the completion of pricing and reimbursement discussions”.
Adam Hill
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