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The experts are against the request to market baclofen, filed by the laboratory Ethypharm, in the treatment of alcoholism. The opinion was made public Thursday by the Agence du médicament. The commission, which met on 3 and 4 July, nevertheless remains in favor of continuing the use of this drug for alcohol addicts, under certain conditions.
The opinion delivered by the committee is advisory and the final decision to authorize the placing on the market of baclofen belongs to the ANSM. It should be taken "at the earliest at the start of the school year," said the Agence du médicament.
If the experts say they "are against the application for marketing authorization as proposed by the laboratory Ethypharm" , they "propose that the use of baclofen can continue" under several conditions.
Not more than 80 mg / day
The commission envisages it in particular "after failure of the available therapeutics with the objective of a reduction of alcohol consumption to a level of low risk consumption (less than or equal to 40 g / d for men and less than or equal to 20 g / d for women) ". The drug can be prescribed "by any doctor up to the dosage of 80 mg / day."
Beyond this dose, "the prescriber must systematically offer the patient a multidisciplinary badessment and management specializing in addiction therapy. , including an increase in the frequency of serious adverse events with increased doses. "
In July 2017, the ANSM lowered the maximum daily dose to 80 mg, compared to 300 previously. The Drug Agency had justified the reduction in light of a study that says high-dose baclofen (more than 180 mg per day) more than doubles the risk of death compared to other drugs for alcoholism, and increases by half the risk of hospitalization
Necessary psychotherapeutic care
For the commission of experts, it is also necessary to badociate the prescription of baclofen "with a psychotherapeutic and / or psychocorporal management and / or social, systematic "and refer the patient for advice or follow-up to a psychiatrist in case of psychiatric disorders, regardless of the dose of baclofen prescribed.
She also believes that the prescribed dose should be" regularly reevaluated And that "the prescription of baclofen must be accompanied by a booklet for monitoring and promoting the proper use of baclofen."
Relaxing musk ulaire
Baclofen is a medicine prescribed since the 1970s as a muscle relaxant, but its use has gradually been diverted towards the treatment of alcoholism. Since 2014, it is authorized for this purpose, thanks to a temporary recommendation of use (RTU). This authorization remains valid until March 2019, reminds the health agency.
ALSO READ> Patients contest the limitation of dosages of baclofen
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