The judges suspended the marketing authorization for Baclocur because of dosage restrictions imposed by the ANSM, which could reduce the effectiveness of the drug in alcohol withdrawal.
- Baclocur received marketing authorization (MA) to treat alcoholism on June 15, 2020
- But the daily dosage imposed by the ANSM is lower than those currently prescribed by doctors.
- The judges considered that this marketing authorization could “prevent the continuation of treatment at doses greater than 80 mg”
Immediately authorized, immediately suspended. While Baclocur officially became the only baclofen-based medicine authorized for the treatment of alcoholism on June 15, the courts suspended its marketing authorization (AMM).
“We learn that our marketing authorizations are suspendedannounced the manufacturer Ethypharm, to Parisian. This means stopping marketing and withdrawing lots already on the market. For the moment, we do not know if they are all concerned.
Dosage restrictions involved
Judging the daily dose imposed by the ANSM (80mg/day) lower than the doses currently prescribed thanks to the temporary recommendation for use from which the medicine benefits (80 to 300mg/day), lhe Baclohelp collective has filed a summary suspension with the administrative court of Cergy-Pontoise (Val-d’Oise).
ANSM’s restrictions are based on a study conducted by Health Insurance in 2017, the conclusions of which evoked “increased risk of hospitalization and death” in patients taking daily doses equal to or greater than 180 mg. The ANSM then specified that “this drug is not insignificant and must be handled with great care”.
The judges therefore suspended the marketing authorization for Baclocur, considering that it could “interfere with continued treatment at doses above 80 mg”, specifies the daily. “It’s good news, rejoiced Thomas Maës-Martin, founder of the association at the origin of the summary. IPatients will be able to continue their treatment at the dosage, prescribed by their doctor, between 80 and 300 mg according to their needs..”
A “bluffing” drug
Each year in France, 41,000 deaths are attributable to alcohol (30,000 in men and 11,000 in women), as well as 16,000 deaths from cancer and 9,900 deaths from cardiovascular disease, according to Public health France. Taking this muscle relaxant has allowed many alcoholic patients to wean themselves off.
Samuel, 35, recently explained to France info having attempted periods “abstinence with self-help groups, retreats in monasteries or withdrawal cures”, before finally succeeding in freeing himself from his addiction thanks to baclofen. “That [l’alcool] doesn’t make us hot or cold, it doesn’t call us any more than a bottle of soda or a bottle of waterhe explains. We don’t even think about it anymore! So it’s a step that is quite amazing for someone who has always known this thought, this mode of operation. There is a release that will take things in hand.”
Alcohol dependence has been recognized as a disease since 1978 by the World Health Organization (WHO), which defines it as from “mental and behavioral disorders” related to the frequent ingestion ofalcohol alcoholic.
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