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New treatment strategies for relapse prevention of alcoholism with Selincro (nalmefene)


Dr Dimitrios N. Gelis, MD, DDS, PhD, Otorhinolaryngologist, with special interest in red wine medical propertiew and treatment of alcohol dependence

Damaskinou 46, Korinthos Greece

e-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Alcohol use and dependence are frequent disorders. Despite numerous established psychosocial approaches, relapse to heavy drinking is common in alcohol-dependent patients after detoxification and relapse prevention remains a significant medical challenge [1].

Alcohol dependence belongs to the globally leading health risk factors. There is a large treatment gap in alcohol dependence, and current treatments are only moderately effective in preventing relapse. New treatment modalities, allowing for reduction of alcohol consumption as a treatment goal are needed [2].

Therapeutic success of psychosocial programs for relapse prevention is moderate and could be increased by an adjuvant treatment with the opioid antagonists naltrexone and nalmefene [3].

The opioidergic system plays a crucial role in mediating the rewarding effects of alcohol, in part by modulating dopaminergic neurotransmission in mesolimbic brain areas.

Nalmefene is an alternate opioid receptor antagonist that also targets the kappa opioid receptors and thus offers a different treatment approach to alcoholism.

Studies have shown that opioid antagonists like naltrexone which also targets the kappa opioid receptors are efficient in reducing heavy drinking (alcoholism). The neurobiological mechanism by which opioid modulators affect drinking behavior is based on the strong connection between the endogenous opioid system, the dopamine system and the influence of the CNS stress response.

The opioid system is of crucial importance in the genesis and maintenance of alcohol dependence. Naltrexone- and to a lesser extent nalmefene- is an agent that modulates opioidergic transmission in the CNS and it shows a limited but well-studied efficacy in treating alcohol dependence [4].

Nalmefene provides clinical benefit, constitutes a potential new pharmacological treatment paradigm in terms of the treatment goal and dosing regimen, and provides a method to address the unmet medical need in patients with alcohol dependence that need to reduce their alcohol consumption [5].

At December 21, 2011, Lundbeck submits a European Marketing Authorization Application (MAA) for Selincro™ (nalmefene) for the treatment of alcohol dependence

  • Lundbeck submits an MAA via centralized procedure for regulatory approval of Selincro™ in Europe
  • Selincro™ has a significant potential for helping individuals with alcohol dependence in reducing their alcohol consumption
  • The reduction in heavy drinking days and total alcohol consumption has been seen within the first month of treatment in all three studies and was maintained throughout the 12-months safety study
  • Selincro™ has been shown to be well tolerated
  • Selincro™ is the first medicine aimed at regulatory approval in Europe for the reduction of alcohol consumption in patients with alcohol dependence.

In December 2012, Lundbeck received a positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization of SelincroTM (nalmefene) for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high level of alcohol consumption. (Stock Exchange Release 14 December, 2012).

The  Committee for Medicinal Products for Human Use [CHMP] opinion was based on the results from three pivotal, randomized, double-blind, placebo controlled clinical trials studying the effects of 18 mg Selincro in adult patients with alcohol dependence.  These studies included approximately 2,000 patients diagnosed with alcohol dependence; two-thirds of these patients had never before received treatment for their disease

SelincroTM (Nalmefene) product profile

Selincro is a small molecule opioid receptor modulator that inhibits the reward pathway in the brain that reinforces the desire and craving for alcohol and other addictive substances. As a result, Selincro targets a novel principle in the treatment of alcohol dependence by removing a person’s desire to drink.

Selincro builds on a novel principle of treating alcohol dependence. Unlike existing therapies, treatment with Selincro is not aimed at keeping the patients from drinking. Instead, Selincro helps to control and limit the intake of alcohol. Selincro distinguishes itself by being available as a tablet formulation to be taken only according to need, ("as needed"), whereas existing pharmaceuticals must be taken continuously over a longer period of time and are aimed at maintaining abstinence.


1, Soyka M, Rösner S. Nalmefene for treatment of alcohol dependence. Expert Opin Investig Drugs. 2010 Nov;19(11):1451-9. doi: 10.1517/13543784.2010.522990. Epub 2010 Sep 25.

2. Rösner S, Hackl-Herrwerth A, Leucht S, Vecchi S, Srisurapanont M, Soyka M. Opioid antagonists for alcohol dependence. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD001867. doi: 10.1002/14651858.CD001867.pub2.

3. Mann K, Bladström A, Torup L, Gual A, van den Brink W. Extending the Treatment Options in Alcohol Dependence: A Randomized Controlled Study of As-Needed Nalmefene. Biol Psychiatry. 2012 Dec 10. pii: S0006-3223(12)00942-0. doi: 10.1016/j.biopsych.2012.10.020. [Epub ahead of print].

4. Hillemacher T, Heberlein A, Muschler MA, Bleich S, Frieling H. Opioid modulators for alcohol dependence. Expert Opin Investig Drugs. 2011 Aug;20(8):1073-86. doi: 10.1517/13543784.2011.592139. Epub 2011 Jun 9.

5.  Mann K, Bladström A, Torup L, Gual A, van den Brink W.Extending the Treatment Options in Alcohol Dependence: A Randomized Controlled Study of As-Needed Nalmefene. Biol Psychiatry. 2012 Dec 10. pii: S0006-3223(12)00942-0. doi: 10.1016/j.biopsych.2012.10.020. [Epub ahead of print]

Last Updated (Friday, 16 August 2013 21:49)

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