drugs

Selincro - Nalmefene

What is Selincro - Nalmefene?

Selincro is a medicine that contains the active substance nalmefene, available as tablets (18 mg).

What is Selincro - Nalmefene used for?

Selincro is used to help reduce alcohol consumption in adults with alcohol dependence who consume more than 60 g of alcohol per day (for men) or more than 40 g of alcohol per day (for women).

The medicine should only be prescribed in combination with psychosocial support and only in subjects who do not have physical withdrawal symptoms and who do not require immediate detoxification interventions.

As an indication, a bottle of wine (750 ml; 12% of alcohol content) contains about 70 g of alcohol, while a bottle of beer (330 ml; 5% alcohol content) contains about 13 g of alcohol.

Selincro can only be obtained with a prescription.

How is Selincro - Nalmefene used?

Before starting treatment with Selincro, the patient is required to record his alcohol consumption for a period of two weeks.

During the first visit with the doctor, the patient's clinical status, alcohol dependence and the level of alcohol consumption (based on the patient's report) must be evaluated.

Subsequently, the patient will have to record his alcohol consumption for about two weeks. At the next visit (after two weeks), treatment with Selincro can be undertaken in patients who have continued to have a high alcohol consumption (over 60 g per day for men and over 40 g per day for women).

Treatment must also include psychological support, in order to help the patient reduce alcohol consumption and adhere to treatment.

The patient should take one Selincro tablet by mouth as needed, ie whenever he or she feels the risk of starting to drink. Only one tablet can be taken per day, preferably 1-2 hours before the scheduled time for alcohol consumption. If the patient has started consuming alcohol without taking Selincro, they should take a tablet as soon as possible.

The available data on the use of Selincro, taken from standard clinical studies, refer to a period of 6 to 12 months. Caution is advised if Selincro is prescribed for a period longer than one year.

How does Selincro - Nalmefene work?

The active ingredient in Selincro, nalmefene, binds to some receptors for opiates present in the brain. Opiate receptors play a key role in addictions; by binding to these receptors and modifying their activity, nalmefene contributes to reducing the desire to consume alcohol in subjects accustomed to important consumption.

Selincro does not prevent the effects of alcohol intoxication.

How has Selincro - Nalmefene been studied?

The effects of Selincro were first tested in experimental models before being studied in humans.

Selincro was compared with placebo (a dummy treatment) in two main studies involving 1 322 men and women with alcoholism. All patients also received psychological support, aimed at reducing alcohol consumption and facilitating patient adherence to treatment.

The main measures of effectiveness were the reduction in the number of days of high alcohol consumption and the average daily consumption of alcohol six months after the treatment.

What benefit has Selincro - Nalmefene shown during the studies?

Selincro has been shown to be more effective than placebo in reducing the number of days with high alcohol consumption and daily alcohol consumption.

Significant improvements, usually observed in the first four weeks of treatment, were recorded in patients who already consumed more than 60 g of alcohol per day (in the case of men) or more than 40 g of alcohol per day (in women). In these patients, the number of days with high alcohol consumption in one month decreased from 23 to 10 in the first study and from 23 to 11 in the second study after six months from the start of treatment with Selincro. Daily alcohol consumption with Selincro decreased from 102 g to 44 g in the first study and from 113 g to 43 g in the second study. These data indicate a more marked improvement compared to placebo of about 2.7-3.7 days with high consumption of alcohol per month and about 10-18 g of alcohol per day.

What is the risk associated with Selincro - Nalmefene?

The most common side effects with Selincro (seen in more than 1 patient in 10) are nausea, dizziness, insomnia and headache. Most of these reactions were mild or moderate and of short duration.

Selincro must not be used in people who are hypersensitive (allergic) to nalmefene or any of the other ingredients. It is not indicated in patients taking opiate-containing medicines, in patients who are suffering or who have recently had an opiate addiction, in patients with acute opiate withdrawal symptoms or in patients suspected of having recently used opiates .

The medicine should not be used in patients with severe hepatic or renal insufficiency or who have recently had acute alcohol withdrawal symptoms (including hallucinations, convulsions and tremors).

Why has Selincro - Nalmefene been approved?

The CHMP noted that Selincro was effective in reducing alcohol consumption in men who reported consumption of more than 60 g of alcohol per day and in women who consumed more than 40 g of alcohol per day. Regarding safety, the undesirable effects reported in the studies did not cause particular concern. The CHMP decided that Selincro's benefits are greater than its risks and recommended that it be given marketing authorization.

More information on Selincro - Nalmefene

On 25 February 2013, the European Commission issued a marketing authorization for Selincro, valid throughout the European Union.

For more information on Selincro therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Last update of this summary: 02-2013.