FDA moves on novel therapies for stimulant use disorders

On Wednesday, the US Food and Drug Administration published a new draft guidance to assist sponsors in developing treatments for stimulant use disorders.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.

Among other things, the draft guidance contains recommendations regarding clinical trial design related to evaluating stimulant use disorder treatments. Designing clinical studies to evaluate the safety and effectiveness of stimulant use disorder treatments presents a number of unique challenges - from selecting appropriate populations for studies to determining the most appropriate clinical endpoints - that require careful review.