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The Council of State canceled, on Wednesday 25 November, the suspension of the sale of Baclocur, decided by justice in June, as the only baclofen-based drug authorized to treat alcoholism. The move is a further step in the long-running controversy between baclofen supporters and health authorities, who warn of its risks.
On June 15, the Medicines Agency (ANSM) authorized the marketing of Baclocur to combat alcoholism. This decision was suspended two days later by the administrative court of Cergy-Pontoise, motivating the patient association “Baclohelp”, which favors baclofen, but which considers the dose limit imposed for prescribing this drug too low.
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 be re-prescribed to alcoholic patients with exceptional authorization and not a marketing authorization permanent (MA), such as that available to Baclocur. And without a limit dose.
The Cergy-Pontoise court had justified its decision since “Risk of discontinuation of treatment” that the limitation of allowable doses with Baclocur has caused patients who previously took larger amounts of baclofen to rush.
Limit of 80 mg / day
In October 2018, 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 overturned the June interim suspension, 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 collective “Baclohelp”, told Agence France-Presse (AFP), who is now awaiting the examination of the merits 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 towards 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 licensed for the treatment of alcoholism since 2014 through a recommendation for temporary use (RTU).
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