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Lundbeck's Selincro cuts alcohol consumption by two-thirds

Licensed from Biotie Therapeutics and Lundbeck hopes to launch the drug in 2013

People dependent on alcohol were able to reduce their consumption by two thirds on average after taking Lundbeck's Selincro for six months, according to data from three phase III trials.

Moreover, the effects of Selincro (nalmefene) on alcohol intake were maintained after one year of treatment, suggesting the drug was exerting a long-term benefit in these patients, according to the company, which filed the drug for approval in Europe in December 2011.

The three placebo-controlled trials looked at Selincro taken as a single 18mg tablet as needed, in other words on days when the trial subjects were considering drinking alcohol. Other drugs used to treat alcoholism require chronic dosing to exert their effects.

All told almost 2,000 patients were enrolled in the studies, which measured the effect of the drug on heavy drinking days (HDD), defined by consumption of 60g or more of alcohol for men and 40g for women, as well as total alcohol consumption (TAC).

Data from the trials were presented at the ongoing 20th European Congress of Psychiatry in Prague, Czech Republic.

In two trials - ESENSE 1 and ESENSE 2 - Selincro was statistically superior to placebo in reducing HDD, cutting them from 19 to 7 days per month and 20 to 7 days/month, respectively. There was also a fairly strong placebo effect, with HDDs reduced from 20 to 10 days in this group.

Average TAC fell from 85g to 43g/day after six months in ESENSE 1, which was significantly better than placebo, and from 93g to 30g/day in ESENSE 2 which was a positive trend but did not reach statistical significance.

The third study (SENSE) showed that Selincro was better than placebo on both HDD and TAC at most time points, but not at month six. HDDs fell from 15 to 5 days/month with Selincro, while TAC fell from 75g/day to 27g/day.

Lundbeck's head of R&D Anders Gersel Pedersen said: "We look forward to bringing this important and different medicine through regulatory approval to address this disease which has major consequences for the individual, families and for society at large."

The company licensed Selincro from Finnish pharma company Biotie Therapeutics in 2008, and has said it expects to launch the drug in its first markets in 2013. Analysts have predicted that the product could achieve sales upwards of $250m a year if approved.

5th March 2012

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