Safety of nalmefene for the treatment of alcohol use disorder: an update

Abstract

Reduced drinking has been debated as a treatment goal for heavy drinking alcohol dependent patients, in whom treatment based on abstinence is not always an option. Nalmefene was the first drug approved by the European Medicines Agency (2013) with the indication of reduced drinking in high drinking risk level alcohol dependent patients. Six years after its introduction in Europe, data from clinical experience can be compared with those from preclinical studies and pivotal registration studies to evaluate what nalmefene has added to the treatment of AUD. Areas covered: Systematic review of efficacy and safety data of nalmefene use in humans from preclinical, phase III and phase IV studies, including systematic reviews, meta-analyses, costeffectiveness analyses and other secondary analyses. Expert opinion: Nalmefene introduces a paradigm change in the treatment of AUD that make it appealing to patients that are reluctant to embrace abstinence, and facilitate patientcentered care in heavy users. However, information regarding safety data in special populations (e.g., patients with alcohol-related diseases, pregnancy, psychiatric disease), and direct comparisons with other potential drugs for alcohol reduction are further needed. Despite the promising role of nalmefene, there are still some factors that limit its wide prescription further than in specialized settings.

GABAergic signaling in alcohol use disorder and withdrawal: pathological involvement and therapeutic potential

“…It can help control alcohol intake and has shown better results in those benefiting from psychosocial support. It has mild side effects, which generally disappear with time (Paille and Martini, 2014;López-Pelayo et al, 2020).…”

Treatment of alcohol use disorder in patients with alcohol-associated liver disease: Innovative approaches and a call to action

“…Nalmefene is another opioid receptor antagonist that is not associated with significant liver toxicity, but caution may be exercised as its clearance diminished in end-stage liver disease [ 61 ]. Nalmefene is approved in Europe for the reduction of alcohol use among those with unhealthy alcohol use [ 8 ].…”

“…Nalmefene is approved in Europe for the reduction of alcohol use among those with unhealthy alcohol use [ 8 ]. Because abstinence rather than reduction in drinking is often the treatment goal for patients with ALD, use of nalmefene may be less relevant in this setting [ 8 , 61 ].…”