Stimulant Use Disorders: Developing Drugs for Treatment; Draft Guidance for Industry; Availability

https://www.federalregister.gov/documents/2023/10/05/2023-22189/stimulant-use-disorders-developing-drugs-for-treatment-draft-guidance-for-industry-availability Today, the U.S. Food and Drug Administration published a new draft guidance to assist sponsors in developing treatments for stimulant use disorders. The guidance, Stimulant Use Disorders: Developing Drugs for Treatment, when finalized, will be the first to provide the FDA’s current thinking on the overall development program and clinical trial design to develop drugs and biologics to support treatment of moderate to severe cocaine use disorder, methamphetamine use disorder and prescription stimulant use disorder. “Currently there is no FDA-approved medication for stimulant use disorder. When finalized, we hope that the guidance will support the development of novel therapies that are critically needed to address treatment gaps," said Marta Sokolowska, Ph.D., deputy center director for Substance Use and Behavioral Health in FDA’s Center for Drug Evaluation and Research. “The guidance is one of the actions within the agency’s Overdose Prevention Framework, which includes appropriate prescribing of prescription stimulants as well as development of evidence-based treatments for stimulant use disorder.”