Nalmefene (trade name Selincro) has been approved since February 2013 for people with alcohol dependence who currently drink a lot of alcohol, but who do not have physical withdrawal symptoms and who do not require immediate detoxification. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether the drug offers an added benefit over the appropriate comparator therapy in this patient group. 

According to the findings, such an added benefit is not proven: In its dossier, the drug manufacturer only presented data for an indirect comparison with the appropriate comparator therapy naltrexone. These data are unsuitable, however. In six out of seven studies on naltrexone, patients and treatment goals differ fundamentally from the ones in the nalmefene studies. In the seventh study, naltrexone was temporarily not used in compliance with the approval, and there were no analyses for relevant periods of time in the study.

For more details, go to: https://www.iqwig.de/en/press/press-releases/press-releases/nalmefene-for-alcohol-dependence-added-benefit-not-proven.6458.html