Lundbeck will be celebrating news that European regulators have issued a green light for Selincro, making it the first therapy approved for the reduction of alcohol consumption in dependent adults.
Selincro (nalmefene) is a unique dual-acting opioid system modulator that acts on the brain’s motivational system, which is dysregulated in patients with alcohol dependence.
The once daily pill has been developed to be taken on days when an alcoholic feels at greater risk of having a drink, in a strategy that aims to reduce - rather than stop - alcohol consumption, which some experts believe is a more realistic goal.
Clinical trials of the drug have shown that it can reduce alcohol consumption by approximately 60% after six months treatment, equating to an average reduction of nearly one bottle of wine per day.
In March last year, data was published from two Phase III trials, ESENSE 1 and ESENSE 2, showing that the mean number of heavy drinking days decreased from 19 to 7 days/month and 20 to 7 days/month, while TAC fell from 85 to 43g/day and from 93 to 30g/day at month six. However, the placebo effect was also strong in the studies.
According to Anders Gersel Pedersen, Executive Vice President and Head of Research & Development at Lundbeck, Selincro "represents the first major innovation in the treatment of alcohol dependence in many years," and he added that its approval "is exciting news for the many patients with alcohol dependence who otherwise may not seek treatment".
Alcohol dependence is considered a major public health concern, and yet it is both underdiagnosed and undertreated, highlighting the urgent need for better management of the condition.
In Europe, more than 90% of the 14 million patients with alcohol dependence are not receiving treatment, but research suggests that treating just 40% of these would save 11,700 lives each year.
The Danish firm said it expects to launch Selincro in its first markets in mid-2013, and that it will provide the drug as part of "a new treatment concept that includes continuous psychosocial support focused on the reduction of alcohol consumption and treatment adherence".