- Finally, Baclofen will 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 (MA) of 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”, notes the ANSM in a press release.
The highest dose indicated is 80 mg / day, according to the ANSM
Following the decision to suspend marketing authorizations for Baclocur specialties (10, 20 and 40 mg) taken by the Cergy-Pontoise Administrative Court on June 17, 2020, the ANSM had referred the matter to the State Council of cassette appeal. The Council of State revoked this suspension decision on November 25, 2020.
“Access to baclofen in alcohol dependence is still possible for patients under the provisional recommendation for use (RTU) in the absence of a marketing authorization drug. The alcohol dependence market”, identifies the ANSM.
The ANSM recalls, whether in the context of the provisional recommendation for use or the marketing authorization, the maximum dose indicated is 80 mg / day, given the increased risk of recurrence side effects beyond this dose. The risks associated with the use of baclofen increase with the dose, which is being discussed among healthcare professionals. health.
“Drugs alone can’t cure alcoholism”
“Baclofen can treat some patients with alcoholism. We have found these to be a clinical reality. And, important to emphasize, we do not need to prescribe high doses to get good feedback. The message I want to get across to My colleagues say we have to let it go. We have to let baclofen find its patients, which is not the case at the moment “, explains Amine Benyamina, head of Paul Brousse’s hospital department who specializes in addiction and is president of the French Confederation. “For the treatment of alcohol addiction, our therapeutic arsenal provides us with many drugs that are no more or less effective than baclofen”, continues the healthcare professional.
Amine Benyamina concludes:“baclofen or not baclofen, drugs alone cannot overcome this disease, which is a multifactorial pathology. The only way currently available to effectively combat alcoholism is comprehensive treatment of the patient. That is, psychology, psychotherapy, social environment development and drug taking (AMM) work “.
In France, an estimated 5 million people have medical, psychological and social difficulties related to their alcohol use.