The Food and Drug Administration (FDA) has issued finalized guidance to help researchers studying the therapeutic benefits of psychedelics navigate the “unique challenges” of such investigations. The agency also announced it will be holding a public hearing on psychedelic therapy issues in September.
“In recent years, interest in the therapeutic potential of psychedelic drugs has been increasing,” the FDA document published on Monday says.
“Drug development programs for psychedelic drugs are subject to the same regulations and same evidentiary standards for approval as other drug development programs,” the agency wrote. “However, designing clinical studies to evaluate the safety and effectiveness of these products presents a number of unique challenges.”
Psychedelics can “cause intense perceptual disturbances and alterations in consciousness that can last for several hours or days,” and can “have both rapid-onset and long-term benefits after only one or a few doses,” FDA said.
The guidance—titled “Psychedelic Drugs: Considerations for Clinical Investigations”—notes that psychedelics are an “an emerging area of drug development” and provides considerations that sponsors of research on substances like psilocybin, LSD and MDMA should take into account.
Among other areas, FDA is providing recommendations on how psychedelic studies handle issues such as chemistry, manufacturing, abuse potential and
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