US FDA To Advance Novel Therapies For Stimulant Disorders

The US Food and Drug Administration (FDA) has released new draft recommendations to help sponsors develop therapies for stimulant use disorders. When it is completed, the guidance, Stimulant Use Disorders:

Developing Drugs for Treatment, will be the first to provide the FDA's current thinking on the overall development program and clinical trial design for developing 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.” Among other things, the draft guidance contains recommendations regarding clinical trial design related to evaluating stimulant use disorder treatments.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, as per pharmabiz. However, there are chances to enhance clinical trial design and establish more person-centered studies, which may result in greater sensitivity to identify a treatment benefit and the possibility of treatment effects being connected to important long-term outcomes. The proposed advice also covers fundamental concerns throughout the drug development process, such as trial design, data collecting, techniques for assessing treatment response, subject safety, and new drug application requirements.