EU Regulators Recommend Selincro Approval
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Selincro, a medicinal product intended for the reduction of alcohol consumption in adults with alcohol dependence.
Selincro is indicated to help lower alcohol consumption in adults with alcohol dependence who have a high drinking risk level (consumption of more than 60 g of alcohol per day for males, and more than 40 g of alcohol per day for females), who do not have physical withdrawal symptoms and who do not require immediate detoxification.
The Committee also recommended that Selincro should be prescribed in conjunction with continuous psychosocial support that focuses on treatment adherence and reducing alcohol consumption. The medicine should only be prescribed to patients who continue to have a high drinking risk level two weeks after initial assessment.
The active substance of Selincro is nalmefene. Nalmefene is an opioid receptor antagonist, which means it blocks the action of certain receptors in the brain called ‘opioid receptors’, which are involved in the complex process of alcohol dependence.
Date: December 19, 2012
Source: European Medicines Agency