Current regulatory perspective on the development of new medications for the treatment of alcohol use disorders (AUD)

In the field of addiction research the ultimate treatment goal in alcohol dependent (AD) patients remains stable abstinence. However, treatment success rates in abstinence-oriented trial settings were modest in the past. Therefore, a clearly significant reduction in alcohol consumption (AC) is suggested as a valid treatment goal in patients not willing or able to immediately engage in treatment approaches aimed at full abstinence. Discussions about the suitability, clinical relevance and regulatory acceptability of study endpoints measuring moderation of drinking are on-going (Anton RF et al. Neuropsychopharmaco…