DRUG - FDA drafts new guidance on psychedelic research
2023-06-23 13:32:08 ET
The U.S. Food and Drug Administration (FDA) published a new draft guidance on investigations into psychedelic drugs on Friday, detailing considerations for their clinical trials for the first time.
The recommendations come at a time when there is growing public interest in the potential of psychedelic drugs such as psilocybin, lysergic acid diethylamide (LSD) and methylenedioxymethamphetamine (MDMA).
Psychedelic drugs are currently under investigation for psychiatric conditions such as depression and post-traumatic stress disorder (PTSD) as well as substance use disorders.
"However, designing clinical studies to evaluate the safety and effectiveness of these compounds presents a number of unique challenges that require careful consideration," the FDA said.
Citing their psychoactive effects, such as mood changes that can lead to abuse, the agency notes that developers of psychedelic drugs should carefully design and implement safety measures to prevent misuse throughout clinical development.
According to the draft guidance, clinical trials on psychedelics classified as Schedule I controlled substances should meet Drug Enforcement Administration (DEA) regulatory requirements.
The draft recommendations are open for public comments for 30 days before the FDA issues its final guidance.
Drugmakers with psychedelic drugs in development include: Bright Minds Bioscience ( DRUG ), Mind Medicine (MindMed) ( NASDAQ: MNMD ), Cybin Inc. ( NYSE: CYBN ), 180 Life Sciences Corp. ( ATNF ), COMPASS Pathways ( NASDAQ: CMPS ), Atai Life Sciences ( ATNF ), GH Research ( GHRS ), Seelos Therapeutics ( NASDAQ: SEEL ), Numinus Wellness ( OTCQX:NUMIF )
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FDA drafts new guidance on psychedelic research