The US Food and Drug Administration (FDA) has published a draft guidance that for the first time offers recommendations for drug development and clinical trial design for therapeutics for stimulant use disorder, including use of cocaine, methamphetamine, and prescription stimulants.
“Currently there is no FDA-approved medication for stimulant use disorder,” Marta Sokolowska, deputy center director for substance use and behavioral health at FDA’s Center for Drug Evaluation and Research (CDRH), said in a statement. “When finalized, we hope that the guidance will support the development of novel therapies that are critically needed to address treatment gaps.”
The draft guidance, published on 5 October, is one piece of the FDA’s Overdose Prevention Framework, according to the agency, which encompasses appropriate prescribing and the development of evidence-based treatments for stimulant use disorder…
