FDA's Initiatives to Accelerate Development of Treatments for Stimulant Use Disorders and Addiction

The U.S. Food and Drug Administration (FDA) has released a draft guidance to assist sponsors in developing treatments for stimulant use disorders, including cocaine use disorder, methamphetamine use disorder, and prescription stimulant use disorder. The guidance aims to address the lack of FDA-approved medications for these disorders and provides recommendations for clinical trial design and drug development processes. The FDA encourages the development of novel therapies and person-centered trial designs to improve treatment outcomes. Stakeholders have 60 days to provide comments on the draft guidance.