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France Grants an Approval to Baclofen for Alcohol Dependence

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Rolland, Benjamin | Simon, Nicolas | Franchitto, Nicolas | Aubin, Henri-Jean

Edité par CCSD ; Oxford University Press (OUP) -

International audience. In October 2018, France became the first country to officially approve baclofen for alcohol dependence. The French Medicines Agency (ANSM) granted a marketing authorization for baclofen, following the request of the French pharmaceutical company Ethypharm (https://www.ansm.sante.fr/S-informer/Communiques-Communiques-Points-presse/L-ANSM-octroie-une-autorisation-de-mise-sur-le-marche-pour-une-utilisation-du-baclofene-dans-l-alcoolo-dependance-Communique). The approval has been given for ‘supporting drinking reduction in alcohol dependence after failure of other approved drugs’. The maximum authorized dose is 80 mg per day. However, it is also stated in the approval that the ‘doses should be progressively increased to reach an optimal posology adjusted to each patient’.[...]

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