In June 2020, baclofen, a treatment for alcohol dependence, was withdrawn from the market. The Council of State canceled this suspension in a decision dated November 25.
- Baclofen will finally be back on the market in a few weeks.
- “The only way we currently have to effectively combat alcoholism is comprehensive patient care.”
It’s a real legal soap opera. The Council of State finally canceled the decision to suspend the marketing authorization (AMM) for Baclocur, a baclofen-based drug, used to treat alcohol dependence. “As a result, this drug can be marketed in accordance with its marketing authorization, granted by the ANSM in October 2018”, specifies the ANSM in a press release.
The maximum indicated dose is 80mg/day, according to the ANSM
Following the decision to suspend the marketing authorizations for Baclocur specialties (10, 20 and 40 mg) taken by the Administrative Court of Cergy-Pontoise on June 17, 2020, the ANSM had seized the Council of State of an appeal in cassation. The Council of State canceled this suspension decision on November 25, 2020.
“Access to baclofen in alcohol dependence is still possible for patients under the temporary recommendation for use (RTU) in the absence of the marketing of a drug with marketing authorization. the market in alcohol dependence”, specifies the ANSM.
The ANSM recalls, whether in the context of the temporary recommendation for use or in that of the marketing authorization, that the maximum dose indicated is 80mg/day, taking into account the increased risk of occurrence of side effects beyond this dosage. The risks associated with the use of baclofen increase with the dose, which is debated among health care professionals. health.
“Medication alone cannot cure alcoholism”
“Baclofen can cure some patients with alcoholism. We have seen it, these are clinical realities. And, it is important to emphasize, we do not need to prescribe high doses to have good feedback. The message that I want to convey with my colleagues is in a way that we have to let things happen. We have to let baclofen find its patients, which is not the case for the moment”, explains Amine Benyamina, head of service at the Paul Brousse hospital specializing in addictology and president of the French Federation of addictology. “To treat alcohol addiction, our therapeutic arsenal provides us with many drugs that are neither more nor less effective than baclofen”, continues the health professional.
Amine Benyamina recalls in conclusion:“baclofen or no baclofen, drugs alone cannot overcome this disease, which is a multifactorial pathology. The only means currently available to combat alcoholism effectively is comprehensive management of that is to say a work of psychology, psychotherapy, an arrangement of the social environment and the taking of drugs which have the marketing authorization (AMM)”.
In France, an estimated 5 million people have medical, psychological and social difficulties related to their alcohol consumption.
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