Baclofen, sold in France under the name Lioresal, is a muscle relaxant prescribed to fight against “spastic contractures of multiple sclerosis, medullary or cerebral diseases”. But it was more and more prescribed outside of this indication, that is to say “without marketing authorization”, to treat alcohol dependence.
The popularity of this drug exploded in 2008 with the publication of the book “The last glass” by Olivier Ameisen, who had self-tested. Having become an alcoholic, this cardiologist, who died last year, told how, with this drug taken in very high doses, he had suppressed his desire to drink. To date, several tens of thousands of French patients therefore receive off-label baclofen in the treatment of their alcohol dependence.
Baclofen: the terms of the temporary authorization
The Medicines Agency (ANSM) today gave its official green light for the use of baclofen in the treatment of alcoholism via a temporary authorization procedure. Temporary because two multicenter clinical trials are currently underway in France and the ANSM is still awaiting their results.
“Widely widespread”, its use in this field “was until now neither recognized nor supervised”, underlined the Minister of Health Marisol Touraine, who was delighted on Friday of this RTU which “offers a framework of safe for use by physicians and patients. “
Baclofen may be prescribed after failure of other available treatments in alcohol-dependent patients in the following two indications:
– Helps maintain abstinence after withdrawal in alcohol-dependent patients
– Major reduction in alcohol consumption down to the low level of consumption as defined by the WHO in high-risk alcohol-dependent patients.
The follow-up protocol defines the procedures for prescribing and monitoring patients, who must be accompanied by psycho-social care, necessary in this pathology.
