The Council of State canceled the suspension of the sale of Baclocur, decided by the justice in June, only two days after the beginning of its marketing as the only drug based on baclofen authorized to treat alcoholism.
In June, the administrative court of Cergy-Pontoise suspended the sale of the drug for interim relief, ruling in favor of the Baclohelp patient association, which favors baclofen but considers the limit dose imposed to prescribe this drug too low.
This decision had brought about a return to the previous situation: other baclofen-based drugs could again be prescribed to alcoholic patients under an exceptional authorization and not a permanent marketing authorization (MA). , like the one available to Baclocur. And without a limit dose.
In October 2018, the Medicines Agency (ANSM) granted Baclocur (Etypharm laboratory) an MA making it the only baclofen-based drug authorized against alcoholism. Decision entered into force in June, but with a maximum dose requirement of 80 mg / day.
In its decision on Wednesday, the Council of State canceled the interim suspension of June, noting that under certain conditions “a pharmaceutical specialty may be the subject of a prescription that does not comply with its marketing authorization”. So beyond the limit of 80 mg / day.
“I am quite satisfied despite everything, even if it is a defeat”, told AFP Thomas Maës-Martin, president of the Baclohelp collective, who is now awaiting the examination on the merits of the case by the administrative court of Cergy-Pontoise.
The move is a further step in the long controversy between supporters of baclofen and health authorities, who warn of its risks.
This product has been used since the 1970s as a muscle relaxant, but its use has gradually been diverted to the treatment of alcoholism.
This alternative use exploded in 2008 with the publication of the book “The last glass” by cardiologist Olivier Ameisen.
Since 2014, baclofen has been authorized for the treatment of alcoholism through a temporary recommendation for use (RTU).