Nalmefene for reducing alcohol consumption in people with alcohol dependence

• Nalmefene is an opioid system modulator with antagonist activity at the mu and delta receptors and partial agonist activity at the kappa receptor
  • Nalmefene as-needed has been shown to reduce the total amount of alcohol consumption and number of heavy drinking days and to improve liver function and clinical status in two published 6-month studies in patients with alcohol dependence (1,2)
    
    
  • Nalmefene has a marketing authorisation in the UK for 'the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level without physical withdrawal symptoms and who do not require immediate detoxification'
    • the summary of product characteristics states that a high drinking risk level is defined as alcohol consumption of more than 60 g (7.5 units) per day for men and more than 40 g (5 units) per day for women

NICE state (3):

• Nalmefene is recommended within its marketing authorisation, as an option for reducing alcohol consumption, for people with alcohol dependence:
  • who have a high drinking risk level (defined as alcohol consumption of more than 60 g per day for men and more than 40 g per day for women, according to the World Health Organization's drinking risk levels) without physical withdrawal symptoms and
  • who do not require immediate detoxification
• the marketing authorisation states that nalmefene should:
  • only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption and
  • be initiated only in patients who continue to have a high drinking risk level 2 weeks after initial assessment

Reference:

• Gual A, He Y, Torup L, et al. A randomised, double-blind, placebo controlled, efficacy study of nalmefene, as-needed use, in patients with alcohol dependence. Eur Neuropsychopharmacol. 2013 (Epub ahead of print). doi: 10.1016/j.euroneuro.2013.02.006
• Mann K, Bladström A, Torup L, et al. Extending the treatment options in alcohol dependence: a randomized controlled study of as-needed nalmefene. Biol Psychiatry. 2013;73:706-13
• NICE (Novemeber 2014). Nalmefene for reducing alcohol consumption in people with alcohol dependence