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

ABSTRACT

Introduction: 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, cost-effectiveness analyses, and other secondary analyses.

Expert opinion: Nalmefene introduces a paradigm change in the treatment of AUD that makes it appealing to patients that are reluctant to embrace abstinence, and facilitate patient-centered 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.

KEYWORDS:

• Alcohol use disorders
• nalmefene
• safety
• harm-reduction
• adverse effects

Declaration of interest

A Gual has received honoraria from Lundbeck. W Van der Brink has received honoraria from Lundbeck, D&A Pharma, and Novartis for consultancies involving alcohol dependence treatments. H López-Pelayo has received travel grants from the laboratories honoraria and travel grants from Janssen and Lundbeck. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was funded by CERCA Programme/Generalitat de Catalunya. H López-Pelayo received funding from the Spanish Ministry of Science, Innovation and Universities, Instituto de Salud Carlos III through a ‘Rıo Hortega’ contract (CM17/00123), with the support of the European Social Fund. P Zuluaga received funding from the Spanish Ministry of Science, Innovation and Universities, Instituto de Salud Carlos III through a ‘Rıo Hortega’ contract (CM17/00022), with the support of the European Social Fund.