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H Lundbeck A/S Presents New Data on Selincro from Three Phase III Studies

Monday, 8 Apr 2013 02:00am EDT 

H Lundbeck A/S announced the results of the revised analysis of the Phase III program that formed the basis for the approval of Selincro (nalmefene) in the European Union on February 25, 2013. Alcohol dependent patients with high risk drinking level (>60g/day for men, >40g/day for women) treated with Selincro showed a reduction in total alcohol consumption after six months of 57% in study 1 (ESENSE 1)1 and 62% in study 2 (ESENSE 2),2 and after 12 months of 67% in study 3 (SENSE).3. The two identical six-month studies showed that patients treated with Selincro on average reduced their total alcohol consumption by more than 40% within the first month and by approximately 60% after 6 months, and this was statistically significant from placebo. In addition, data from the one-year study confirmed that the positive effects of Selincro are maintained and even improved after one year of treatment, leading to a 67% reduction in total alcohol consumption – equivalent to nearly one bottle of wine per day. In all three studies Selincro was generally well tolerated, and adverse events were mostly mild to moderate and transient.1,2,3. Lundbeck expects to launch Selincro in its first markets in Q2 2013. 

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