Selincro (nalmefene), made by specialist Biotie in partnership with Lundbeck, is claimed to be a breakthrough in the treatment of alcohol dependence.
However, the effect of placebo – reducing alcohol consumption by 50% – in the same trials has weakened the impact of the results.
Selincro is an opioid system modulator that inhibits the reward pathway in the brain, reducing the craving for alcohol and other addictive substances.
Alcohol dependence affects an estimated 14 million people in the EU, but only 13% of these receive any treatment.
The first medicine aimed at reducing alcohol consumption, Selincro is currently being appraised by the EMA.
Lundbeck presented results from three phase III studies, ESENSE 1, ESENSE 2 and SENSE, with almost 2,000 patients – all of whom were given medical advice and support in reducing their alcohol intake. The drug was taken when the patients perceived themselves to be at high risk of drinking.
In ESENSE 1, patients taking Selincro showed a decline in heavy drinking days per month from 19 to 7 and in alcohol consumption from 84g to 30g per day; patients on placebo showed a drop from 20 days to 10 and 85g to 45g per day.
In ESENSE 2, the Selincro arm showed a drop from 20 to 7 days and from 93g to 30g; the placebo arm showed a drop from 18 to 7 and from 89g to 33g.
In SENSE, the results were: for Selincro, a drop from 15 to 5 days after six months and to 3 days after one year, and from 75g to 22g after six months and 16g after one year; for placebo, a drop from 15 to 6 days and from 75g to 27g after six months, with no further change after one year.
While the differences in outcomes between Selincro and placebo are statistically significant, they are much smaller than the impact of patient guidance and support.
However, Timo Veromaa, CEO of Biotie, commented: “Selincro has the potential to transform the way alcohol dependence is managed by both physicians and patients and we look forward to working with our partner Lundbeck and the regulators to make this important new treatment option available in Europe.”
Biotie has licensed global rights to the product to Lundbeck for an upfront payment of €12m total and a potential further €72m in milestone payments and royalties on sales. Lundbeck will be responsible for manufacturing and seeking regulatory approval for Selincro.
Based in Finland, Biotie specialises in developing treatments to address major unmet needs in neurological, psychiatric and inflammatory diseases. It partners with pharmaceutical companies (including Lundbeck, Roche and UCB) for late-stage development and commercialisation.
The Selincro trial results will fuel debate about the value of placebo-controlled trials relative to head-to-head drug trials.