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IQWiG: Selincro's benefit to heavy drinkers unproven

December 5, 2014 2:09 AM UTC

The German Institute for Quality and Efficiency in Health Care (IQWiG) said H. Lundbeck A/S (CSE:LUN) did not show Selincro nalmefene offered benefit over comparator naltrexone to reduce alcohol consumption by adults with dependence who have a high drinking risk level without physical withdrawal symptoms and who do not require immediate detoxification.

IQWiG said Lundbeck provided unsuitable data that did not allow it to compare Selincro with naltrexone directly. Among 11 studies, Lundbeck provided six in which naltrexone patients who abstained from alcohol at the start of treatment were compared with Selincro patients who consumed alcohol at high-risk levels. In a seventh study, IQWiG said naltrexone was not administered in a manner compliant with its label. Four studies compared Selincro with placebo. ...