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H Lundbeck A/S and Biotie Therapies Oyj Receive Positive Opinion for Approval of Selincro (Nalmefene) in European Union

Friday, 14 Dec 2012 07:08am EST 

H Lundbeck A/S (Lundbeck) announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted a positive opinion and recommended marketing authorization of Selincro for the reduction of alcohol consumption in adult patients with alcohol dependence. Once approved, Lundbeck will provide Selincro as part of a new treatment concept that includes continuous psychosocial support focused on the reduction of alcohol consumption and treatment adherence. For many patients with alcohol dependence, to entirely stop and abstain from drinking is not an acceptable or attainable treatment goal. Selincro will be the first medication specifically developed for the reduction of alcohol consumption in patients with alcohol dependence who maintain a high level of alcohol consumption. Selincro reduces alcohol consumption and thus the consequences of harmful drinking, and offers a new treatment option for patients who may not have sought treatment before. Selincro is an opioid system modulator that works on the brain’s motivational system. The CHMP opinion was based on the results from three pivotal, randomized, double-blind, placebo controlled clinical trials studying the effects of 18 milligrams of Selincro in adults patients with alcohol dependence. These studies included approximately 2,000 patients diagnosed with alcohol dependence; two-thirds of these patients had never before received treatment for their disease. 

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