France is the first country to license baclofen for alcoholism treatment. A recommendation for temporary use was issued on 14 March 2014 for a period of 3 years. The trials of baclofen are scheduled to end in May 2014 and the results will then be compiled so that the RTU will, in all likelihood, result in the drug being licensed permanently.
Baclofen TMP approval in France as treatment for alcoholism
On 13 March 2014 Baclofen received a TMP approval in France as treatment for alcoholism.
Is called “RTU – Recommandations temporaire d’utilisation” (Temporary Recommendation of Use) and is a special authorization/dispositive/protocol created to permit an “on label” prescription of a drug while waiting for final results of more Clinical Trials.
Here the official news by the ANSM (French FDA) and the explanation of what it is :
Recommandations temporaire d’utilisation du Baclofène dans le traitement de l’alcoolo-dépendance
Temporary recommendations for the use of baclofen in the treatment of alcohol dependence
What is the RTU? What kind of approval Baclofen received?
– Recommandations temporaire d’utilisation
– Temporary Recomendation of Use
Worldwide news coverage.
French articles:
– Le Monde – Alcoolisme : feu vert officiel à la prescription de baclofène
– Le Figaro – Alcoolisme : les autorités donnent le feu vert au baclofène
– lequotidiendumedecin.fr Baclofène : une autorisation « historique » enfin, mais encore restreinte
– Liberation – Le Baclofène autorisé pour traiter l’alcoolisme
many others…
News in English (USA/UK):
Notes: the only news is not FREE access and the other just mention the approval. Practically invisible in English speaking websites!
– French formalize off-label use of baclofen in alcoholism (article only for subscribers!)
– Could the Cure for Alcoholism Be Lying Dormant on FDA Shelves? (just a short note – article originally published here: “Baclomania: The Cult Of A Cure For Alcoholism)
News in Spanish (Spain/Latin America):
Notes: the Press Realease (EFE agency) mistakes Baclofeno with “blacofène” and talks about “gramos” in place of “miligramos”.
– En Francia autorizan un relajante muscular como medicamento contra el alcoholismo
– La eficacia de los medicamentos para combatir el alcoholismo divide a la comunidad científica
Same press realease in many other wesites: “blacofène” – baclofeno EFE Press Release
News in German (Germany) – ENG translated:
– welt.de Frankreich lässt Baclofen gegen Alkoholismus zu
– aerzteblatt.de Frankreich: Baclofen zur Förderung der Alkoholabstinenz „vorläufig“ zugelassen
– Web.De: Baclofen for alcoholism in France approved
– Gesundheit.de: Baclofen for alcoholism in France approved
– N-TV: Baclofen for alcoholism in France approved
– Berliner Morgenpost: France admits Baclofen for alcoholism
– Onmeda.de: Drug for alcoholism
– Abbreviated, “Die Zeit”: Approved drug Baclofen in France against alcoholism
– LifeLine: Baclofen: A pill against alcohol addiction
News in Italian (Italy):
– Francia, autorizzato il farmaco per curare l’alcolismo
News in Dutch (Holland):
News in Portuguese (Portugal/Brasil):
BACLOFENISTA 