Lundbeck and partner Biotie Therapeutics Corp have been boosted by promising data from three late-stage studies on the alcohol dependence drug Selincro.
The Danish drugmaker has presented results from the Phase III trials at the European Congress of Psychiatry in Prague which support the efficacy and tolerability of Selincro (nalmefene) in reducing consumption in patients with alcohol dependence. A total of 1,997 patients were randomised in the three studies, evaluating the efficacy of as-needed use of Selincro versus placebo in reducing the number of heavy drinking days (HDD), ie at least 60g alcohol for men and at least 40g for women, and the monthly total alcohol consumption (TAC) over a period of six months in alcohol dependent patients.
In two of the trials, ESENSE 1 and ESENSE 2, the mean number of HDDs 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 6. However, the placebo effect was also strong in the studies.
Anders Gersel Pedersen, head of R&D at Lundbeck, said the firm is "very encouraged by these data of Selincro, its efficacy in reducing heavy drinking days and total alcohol consumption combined with a favourable safety and tolerability profile". The drug, which has a modulating effect on the cortico-mesolimbic system, was filed in Europe in December.
Lundbeck licensed the rights to Selincro from Biotie in 2008, paying an execution fee of 12 million euros. The Finnish firm is eligible to receive up to 84 million euros in upfront and milestone payments plus royalties.