The EU Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of the marketing authorisation for Selincro, a medicinal product intended for the decrease in drinking in adults with alcohol dependence.
Selincro is indicated that can help lower alcohol consumption in older adults with alcohol dependence with a higher drinking risk level (usage of greater than 60 g of alcohol on a daily basis for males, and more than 40 g of alcohol per day for women), that n’t have physical withdrawal symptoms and that do not require immediate detoxification.
The Committee also recommended that Selincro needs to be prescribed in conjunction with continuous psychosocial support that targets treatment adherence and reducing drinking. The medicine should only be prescribed to patients who continue to have a superior drinking risk level 14 days after initial assessment.
The active substance of Selincro is nalmefene. Nalmefene is surely an opioid receptor antagonist, this means it blocks the action of certain receptors inside the brain called ‘opioid receptors’, which can be involved in the complex technique of alcohol dependence.
Impact of harmful alcohol use on public health
Alcohol dependence is a psychiatric disorder with harmful physical, mental and social consequences. It truly is characterised by craving, tolerance, a preoccupation with alcohol and continued drinking even though harmful effects.
It really is considered a significant public-health problem. In Europe, the prevalence of alcohol dependence is estimated at 5-6% in males and 1-2% in females. Harmful by using alcohol is related to premature death and avoidable disease, which is a significant avoidable risk factor for neuropsychiatric disorders, cardiovascular diseases, cirrhosis and cancer.
In line with the Agency’s ‘Guideline within the growth and development of medicinal products to the treatments for alcohol dependence’, adopted through the CHMP this season, the supreme treatment goal in alcohol-dependent patients is abstinence, reduction in frequency and severity of relapse, and improvement in health insurance and psychosocial functioning.
The CHMP’s opinion on Selincro will now be sent to the European Commission for that granting of the marketing authorisation.
Source: EMA News Release
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