Die Zulassung von Baclofen bei Alkoholmissbrauch in Frankreich: Aus der US-Perspektive betrachtet (Alcohol and Alcoholism, 2020)

Approval of Baclofen for Alcohol Use Disorders in France: A Perspective From the United States (Alcohol and Alcoholism, 2020)
Autor: James C. Garbutt
(pp, 11.01.2020)

Abstract im englischen Original

The recent approval of baclofen for the treatment of alcohol use disorders (AUDs) in France is notable as baclofen is now the sixth chemical entity (disulfiram, calcium carbamide, naltrexone, acamprosate, nalmefene and baclofen) to obtain approval by a government agency as a medication for AUDs. The approval noted that baclofen is indicated ‘. . . following failure of other available medical treatments in adults with alcohol dependence and high-risk alcohol consumption (>60 g/day for men or >40 g/day for women)’ and that dose should not exceed 80 mg/day. This can be viewed as a positive sign that the scientific understanding of AUDs continues to advance, and we are at the point where pharmacology is being brought into the clinic. However, this approval also brings up questions—Is there sufficient evidence of efficacy and safety for baclofen to merit approval at this time? Do we have any understanding of who should receive baclofen? What are the prospects for approval of baclofen in the USA?

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