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Psychedelics Today

PT556 – The FDA, MDMA, and Public Perception: Was the FDA Fair to Lykos?, with Rick Doblin, Ph.D.

Oct 15, 2024
Rick Doblin, Ph.D., is the founder of MAPS and a pioneer in psychedelic research. In this discussion, he shares insights on the FDA's handling of MDMA trials, emphasizing miscommunications that led to setbacks for Lykos Therapeutics. Doblin argues that neglecting public perception was a critical mistake and explores the bias at the FDA. He also highlights the need for better public education and drug policy reform, contrasting U.S. and European regulatory approaches while discussing innovative international MDMA therapy initiatives.
01:13:02

Episode guests

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Quick takeaways

  • The FDA's shifting requirements during the MDMA approval process highlight the increasing caution around psychedelic substances and their therapeutic applications.
  • Public perception, influenced by media portrayal, plays a critical role in shaping FDA decisions, emphasizing the need for transparent communication from advocates.

Deep dives

Regulatory Developments in MDMA Research

Recent FDA negotiations surrounding the approval process for MDMA have been pivotal in shaping its future in therapeutic settings. The dialogue acknowledged the complexities of creating a double-blind study when using such an impactful substance, necessitating a focus on dosage to ensure proper efficacy and safety. Studies highlighted that lower doses of MDMA could lead to therapeutic improvements, yet these doses were not as effective as therapy with no MDMA use, suggesting that careful dosing is essential for optimal outcomes. This rigorous research approach aims to establish a solid evidence base for the approval of MDMA as a treatment for conditions like PTSD.

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