France baclofen medicine against alcoholism

France allows the active substance baclofen for the treatment of alcoholism

03/14/2014

In France, the active ingredient baclofen has been approved for the treatment of alcoholism. The drug, which was developed to treat spasticity, helps keep abstinence after patients have been withdrawn and makes it easier to reduce alcohol consumption to levels recommended by the World Health Organization (WHO) for high-risk patients, according to the French Medicines Agency „Agence nationale de sécurité du médicament et des produits de santé“(ANSM).

The treatment of alcoholism is a major public health issue, and after initial reports of successful treatment for alcohol dependence with baclofen, several clinical trials have been approved to investigate this approach, reports the ANSM. In order to allow patients to receive treatment for their addiction before the completion of the ongoing clinical trials, a temporary license for use of the drug for the treatment of alcohol dependence has now been issued, according to the ANSM communication on Friday in Paris. „Pending the results and analysis of currently available data on the benefit-risk balance“ According to its own statements, the ANSM had to grant provisional approval.

Baclofen originally approved as a muscle relaxant
For 40 years, baclofen has been used as a centrally acting muscle relaxant for the treatment of spasticity. But just over ten years ago, a completely new field of application emerged for the first time. An alcohol-dependent French doctor overcame his own addiction with the help of the drug and thus attracted much attention in the professional world. This was followed by clinical studies with alcoholics whose results confirmed the beneficial effect of baclofen in the treatment of alcoholism. Two large-scale multicentre studies are currently ongoing, but here too, preliminary results show that the drug is well-suited 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, major depression) or severe renal or hepatic impairment.“

Accurate patient monitoring required
In the recommendations of the ANSM is the one for the treatment of alcohol addiction „initial daily dose of 15 milligrams daily“ which is then progressively raised at intervals of two to three days by five to ten milligrams per day, „until there is a clinical reaction.“ This response of the organism and the time to onset can be very variable from one patient to another, which is why the application requires close monitoring, reports the ANSM. Whether other countries will follow the example of France and allow baclofen for the treatment of alcohol addiction remains for the time being open. However, if the final results of the clinical trials confirm the previous assessment, this may only be a matter of time. (Fp)