France approves the active ingredient baclofen for the treatment of alcoholism
In France, the active ingredient baclofen has been approved for the treatment of alcoholism. The drug, which was actually developed for the therapy of spastic paralysis, helps to maintain abstinence after withdrawal from the patient and makes it easier to reduce alcohol consumption to consumption values, as prescribed by the World Health Organization (WHO) for patients with high risk of alcohol addiction, reports the French drug agency " Agence nationale de securité du médicament et des produits de santé ”(ANSM).
The treatment of alcoholism is a major public health problem, which is why ANSM reports that after first reports of successful treatment for alcohol addiction with baclofen, several clinical studies have been approved to explore this approach. In order to enable patients to treat their addiction before the end of the ongoing clinical studies, the drug has now been temporarily approved for the treatment of alcohol addiction, the ANSM announcement on Friday in Paris. "In anticipation of the results and after analysis of the currently available data on the benefit-risk ratio", the ANSM had to grant a preliminary approval.
Baclofen originally approved as a muscle relaxant Baclofen has been used as a central muscle relaxant for the treatment of spastic paralysis for 40 years. But over ten years ago, a completely new area of application emerged. An alcohol-dependent French doctor overcame his own addiction with the help of the active ingredient and thus attracted a lot of attention in the professional world. Clinical studies with alcohol addicts followed, the results of which confirmed the positive effect of baclofen in the treatment of alcoholism. Two large-scale multicentre studies have not yet been completed, but here too the preliminary results show that the active ingredient is perfectly suitable for the treatment of alcohol addiction, reports the ANSM. However, there are some contraindications, such as "severe neurological or psychiatric disorders (uncontrolled epilepsy, schizophrenia, bipolar disorder, severe depression) or severe kidney or liver dysfunction."
Close monitoring of patients required The recommendations of the ANSM call the “initial daily dose of 15 milligrams per day” for the treatment of alcohol addiction, which is gradually increased by five to ten milligrams a day at intervals of two to three days , "Until a clinical reaction appears." This response of the organism and the time until it occurs can vary greatly from one patient to another, which is why the application requires close monitoring, reports the ANSM. It remains to be seen whether other countries will follow France's example and allow baclofen for the treatment of alcohol addiction. Should the final results of the clinical studies confirm the previous assessment, this should only be a matter of time. (fp)