[ad_1]
The Council of State canceled the suspension of the sale of Baclocur, decided by justice in June, only two days after the start of its commercialization as the only baclofen-based drug authorized to treat alcoholism.
In June the administrative court of Cergy-Pontoise suspended the sale of the drug summarily, 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 resulted in a return to the previous situation: other baclofen-based drugs could be re-prescribed to alcoholic patients with an exceptional authorization and not a permanent marketing authorization (MA). , such as 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. The decision went into effect in June, but with a maximum required dose of 80 mg / day.
In its decision on Wednesday, the Council of State canceled the provisional suspension of June, noting that under certain conditions “a pharmaceutical specialty may be subject to 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,” Thomas Maës-Martin, president of the Baclohelp collective, told AFP, who is now awaiting the examination of the case by the administrative court of Cergy. -Pontoise.
The move is a further step in the long-running controversy between baclofen advocates and health authorities, who warn of its risks.
This product has been used since the 1970s as a muscle relaxant, but its use was gradually 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.
Baclofen has been authorized in the treatment of alcoholism since 2014 thanks to a temporary recommendation for use (RTU).
Source link
