Impact of regulatory changes on the use of baclofen in alcohol use disorders between 2014 and 2021, using the French National Health Data System

The off-label use of baclofen in the treatment of alcohol use disorders (AUD) increased significantly between 2007 and 2013 in France. In March 2014, a temporary recommendation for use (TRU) was granted, followed by a marketing authorization (MA) in October 2018. In July 2017, the maximum dose was limited to 80 mg/day to limit serious adverse effects related to high doses in a 3rd version of the TRU. The aim of this study was to assess the impact of regulatory changes on baclofen initiations for AUD and compliance with daily dose recommendations between 2014 and 2021 using the French National Health Data System. Time series analyses were performed to evaluate the MA effect and 3rd TRU on initiations and daily doses. A total of 478,109 patients initiated baclofen for AUD between 2014 and 2021. After a maximum in initiations in 2014 ((N = 98,552), initiations declined gradually (N = 48,471 in 2021). The MA had no impact on initiations. The 3rd TRU helped to reduce the number of patients with a high dose, even if majority of patients had doses of less than 80 mg/day (78.0% before vs. 88.3% after 3rd TRU). Regulatory measures have therefore had a slight impact on the use of baclofen.