Alcohol: unfavorable opinion for the commercialization of baclofen – 05/07/2018

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Baclofen is a medication prescribed since the 1970s as a muscle relaxant, but its use has gradually been diverted to the treatment of alcoholism.

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(AFP) – Ad Hoc Expert Panel Rendered "Unfavorable" Opinion on Baclofen's Application for Commercialization of Alcoholism by Ethypharm Laboratory

This Public Notice has been issued Thursday by the ANSM Medicines Agency

The commission, composed of members of the three ANSM advisory committees and which met on 3 and 4 July, remains nevertheless in favor of the continued use of this drug for alcohol dependents, under certain conditions.

However, the final decision to grant marketing authorization (MA) for baclofen from this laboratory belongs to ANSM and will be taken "at the earliest the autumn, "says AFP Agency drug.

Baclofen is a drug prescribed since the 1970s as a muscle relaxant, but the 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 Special Scientific Committee (CSST), had already delivered an unfavorable opinion in April. The CSST considered that the benefit / risk ratio in this indication was negative.