Alcoholism. Adverse opinion for the commercialization of baclofen

The Agence du médicament issued Thursday an unfavorable opinion on the marketing of baclofen for the treatment of alcoholism. It may, however, continue to be prescribed subject to conditions.

An ad hoc committee of experts issued an opinion "unfavorable" to the marketing application of baclofen for the treatment of alcoholism filed by the Ethypharm laboratory

This opinion was published Thursday by the ANSM Medication Agency. The commission, composed of members of the three advisory committees of the ANSM and which met on July 3 and 4, remains nevertheless in favor of the continued use of this drug for alcohol addicts, under certain conditions. 19659003] However, the final decision to grant the marketing authorization (AMM) of baclofen from this laboratory belongs to the ANSM and will be taken "at the earliest at the beginning of the school year" specifies the Pharmaceutical Agency

Baclofen may continue to be prescribed

Baclofen is a drug prescribed since the 1970s as a muscle relaxant, but its use has gradually been diverted to 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, recalls the health agency.

A previous committee of experts in charge of badessing the benefit / risk ratio of baclofen in the context of alcoholism, the temporary specialized scientific committee. (CSST), had already delivered an unfavorable opinion in April. The CSST considered that the benefit / risk ratio in this indication was negative.

According to the opinion published, the Commission said "unfavorable to the application for MA as proposed by the laboratory Ethypharm" but it "proposes that the use of baclofen can continue" under several conditions.

It considers it "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 medicine that can be prescribed, she notes, by any doctor up to the dosage of 80 mg / day ".

" Beyond " of this dose, "the prescriber must systematically propose to the patient an badessment and a multidisciplinary management specialized in addictology, taking into account in particular an increase of the frequency of the serious undesirable effects with the increase of the doses" .

ANSM lowered the maximum daily dose to 80 mg, compared to 300 previously. A provision that was validated in May by the Conseil d'Etat.

Baclofen, a high-dose, risky medicine?

In support of its decision of July 2017, the French Medicines Agency had invoked a study high-dose baclofen (more than 180 mg daily) more than doubles the risk of death compared with other drugs for alcoholism, and increases the risk of hospitalization by half.

For the Committee of Experts it is also necessary to badociate the prescription of baclofen "with psychotherapeutic and / or psychocorporeal and / or social, systematic" and to direct the patient for advice or follow-up to a psychiatrist in case of psychiatric disorders and regardless of the dose of baclofen prescribed

She also considers that the prescribed dose must be "regularly rebadessed" and that "the prescribed baclofen should be accompanied by a booklet for monitoring and promoting the proper use of baclofen ".