The U.S. Food and Drug Administration on Friday issued its first draft guidance on psychedelic drug clinical trials, outlining considerations for companies investigating the drugs’ potential to treat psychiatric and substance-use disorders and other medical conditions. Psychedelics are increasingly drawing attention from researchers, biotech companies and investors interested in their potential to help address the U.S. mental-health crisis. But designing clinical studies to evaluate their safety and effectiveness comes with unique challenges, the FDA said in a statement. The guidance includes considerations for trial conduct, data collection, subject safety and new drug application requirements. Given that the drugs can cause mood and cognitive changes and hallucinations, “there is the potential for abuse of these drugs,” requiring safety measures to prevent misuse throughout clinical development, the FDA said. Companies like Atai Life Sciences ATAI, Compass Pathways CMPS, and Cybin CYBN are already developing therapies based on psychedelic substances.
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