Nalmefene for the treatment of alcohol use disorders: recent data and clinical potential

ABSTRACT

Introduction: Few pharmacotherapies are available for alcoholism. Numerous studies indicate the involvement of the opioid-endorphin system in mediating the reinforcing effects of alcohol via dopaminergic neurons. The opioid antagonist naltrexone was found to be effective in alcohol treatment, and the European Medicines Agency has now approved the mu-opioid antagonist und partial kappa agonist nalmefene.

Areas covered: This article presents background information on the chemistry of nalmefene and pre-clinical and clinical findings. The three relevant Phase III studies, all of which followed a harm-reduction, “as needed” approach and found reduced alcohol consumption with nalmefene 18 (20) mg, are discussed in detail.

Expert opinion: The integration of the “as needed” approach into conventional psychosocial alcohol therapies may be challenging but offers the opportunity to reach otherwise not treated patients. Nalmefene is the first medication to be approved specifically in this indication and seems to be most suitable for patients with alcohol misuse or a rather low physical dependence on alcohol who do not require immediate detoxification or inpatient treatment. Although a categorical distinction between patients who want to stop heavy drinking or drinking at all over time may be somewhat hypothetical, nalmefene offers new treatment options to patients with alcohol use disorder.

KEY WORDS:

• alcohol
• alcoholism
• nalmefene
• opioid antagonists
• opioid receptors
• therapy

Acknowledgements

The author thanks Jacquie Klesing, Board-certified Editor in the Life Sciences (ELS), for editing assistance with the manuscript.

Declaration of Interest

For the past 5 years, M Soyka has worked as a consultant or has received research grants from Sanofi Aventis, Novartis, Mepha, Reckitt Benckiser, and Lundbeck. No funding was used to prepare this narrative. The author has 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