European officials have approved Lundbeck’s Selincro putting it on course to be the first drug available in the region to help reduce consumption of alcohol.
The European Commission (EC) granted marketing approval for Selincro (nalmefene) after it demonstrated it could reduce people’s urge to drink, with trial data showing a 40 per cent reduction on total alcohol consumption within the first month.
This increased to 60 per cent following six months of treatment with Selincro – a figure that corresponds to an average reduction that’s equal to nearly one bottle of wine per day, according to Lundbeck.
In line with the recommendation from the European Medicines Agency’s (EMA) advisory committee, patients treated with Selincro will also receive continuous psychosocial support focused on the reduction of alcohol consumption and treatment adherence.
Professor Karl Mann, head of the department of addictive behaviour and addiction medicine at the Central Institute of Mental Health in Mannheim, Germany, said the treatment offered a “new chapter” in the treatment of alcohol dependence, providing an alternative to complete abstinence.
“For a large proportion of patients with alcohol dependence, reduction of alcohol consumption is a more acceptable and realistic treatment goal,“ he said.
Selincro works by affecting an individual’s opioid receptors, which help to control the brain’s motivational system.
By doing so, the reinforcing effects of alcohol are reduced, resulting in a decrease in the urge to drink alcohol.
Clinical trials have demonstrated these results are maintained after one year of treatment, suggesting a long-term benefit for patients.
The approval is good news for Lundbeck, with the company looking towards new products to mitigate the effect of generic competition for its former lead product, the antidepressant Lexapro (escitalopram).
The Denmark-based firm said it intends to launch Selincro in its first European markets by mid-2013, with new arrival Barbara Jaszewski set to provide a significant contribution as VP of global pricing and market access.