The Readout Loud
309: Psychedelics at the FDA, ASCO recap, & MorphoSys update
Jun 6, 2024
STAT colleague Meghana Keshavan dissects Lykos Therapeutics' meeting with FDA. Topics include challenges in FDA approval for psychedelic therapy, Novartis's acquisition of Morphosis, ASCO conference reflections, and FDA advisory panel vote against MDMA for PTSD.
29:34
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Quick takeaways
- FDA advisory committee raised concerns about MDMA trial design, impacting its use for PTSD treatment.
- Challenges in psychedelic therapy trials underscore the importance of improved trial designs and transparency in research.
Deep dives
Debate Over MDMA for Treating PTSD
A panel of FDA advisors voted against using the psychedelic MDMA for treating post-traumatic stress disorder (PTSD). The negative vote was influenced by concerns about the study's design and conduct rather than a verdict on MDMA's effectiveness. The trial had issues with patient selection, bias, lack of blinding, and missing safety data despite positive outcomes.
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