- Baclofen will finally be back on the market in a few weeks.
- “The only means currently available to effectively combat alcoholism is comprehensive patient care.”
It’s a real judicial soap opera. The State Council finally overturned the decision to suspend the marketing authorization (AMM) of Baclocur, a baclofen-based drug used for the treatment of alcohol addiction. “As a result, this drug can be marketed in accordance with its marketing authorization, issued by ANSM in October 2018,” specifies the ANSM in a press release.
The maximum dose indicated is 80 mg / 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, ANSM had referred the matter to the Council of State appeal in cassation. The State Council overturned this suspension decision on November 25, 2020.
“Access to baclofen in alcohol dependence is always possible for patients under the temporary recommendation for use (RTU) in the absence of the marketing of a drug with a marketing authorization. The addiction market from alcohol “, specifies the ANSM.
The ANSM recalls, both in the context of the temporary recommendation for use and in that of the marketing authorization, that the maximum dose indicated is 80 mg / day, taking into account the increased risk of developing side effects beyond this dosage. Risks associated with baclofen use increase with dose, which is debated among healthcare professionals. Health.
“Drugs alone cannot cure alcoholism”
“Baclofen can cure some patients with alcoholism. We have seen that these are clinical realities. And it is important to point out that we do not need to prescribe high doses to get good feedback. The message I want to convey to my colleagues is that we must let it go. . We have to let baclofen find its patients, which is currently not the case. “ explains Amine Benyamina, head of the department at Paul Brousse hospital specializing in addiction and president of the French Federation of Addiction. “To treat alcohol addiction, our therapeutic arsenal provides us with many drugs that are neither more nor less effective than baclofen”, continues the healthcare professional.
Amine Benyamina recalls in conclusion:“Baclofen or non-baclofen, drugs alone cannot overcome this disease, which is a multifactorial pathology. The only means currently available to effectively combat alcoholism is the comprehensive treatment of the patient. That is to say, a work of psychology, psychotherapy, development of the social environment and the use of marketing authorization drugs (AMM) “.
In France, around 5 million people have medical, psychological and social difficulties related to alcohol consumption.