The Council of State canceled, Wednesday, November 25, the suspension of the sale of Baclocur, decided by the justice in June, as the only drug based on baclofen authorized to treat alcoholism. The move is a further step in the long controversy between supporters of baclofen and health authorities, who warn of its risks.
On June 15, the Medicines Agency (ANSM) authorized the marketing of Baclocur to fight alcoholism. This decision was suspended two days later by the administrative court of Cergy-Pontoise, giving reason to the association of patients “Baclohelp”, favorable to baclofen, but which considers too low the dose limit imposed to prescribe this drug.
Pending a decision on the merits, this urgent judgment (summary judgment) had led to 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), such as that available to Baclocur. And without a limit dose.
The Cergy-Pontoise court had justified its decision by the “Risk of treatment interruption” that limiting the doses allowed with Baclocur caused patients who previously took larger amounts of baclofen to run.
Limit of 80 mg / day
In October 2018, the 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 issued 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 Agence France-Presse (AFP) Thomas Maës-Martin, president of the “Baclohelp” collective, which is now awaiting the substantive examination of the case by the administrative court of Cergy-Pontoise.
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).