FDA Advisory Committee votes ‘No’ on MAPS/Lykos MDMA-assisted therapy approval

25/06/2024 1h 1min Episodio 159
FDA Advisory Committee votes ‘No’ on MAPS/Lykos MDMA-assisted therapy approval

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Episode Synopsis

Send us a textIn today’s episode of the Psychedelic Therapy Frontiers podcast Dr. Steve Thayer and Dr. Reid Robison  talk about the recent FDA psychopharmacologic drugs advisory committee meeting that resulted in a majority vote against the approval of MDMA-assisted therapy for PTSD based on MAPS/Lykos study data. They discuss what the committee’s concerns were, the Institute for Clinical and Economic Review’s (ICER) criticisms of the studies, the challenges of conducting psychedelic clinical trials, functional unblinding, how research and rater bias affects study data, and much more.https://psychedelicalpha.com/news/exclusive-therapists-and-trialists-from-lykos-phase-3-mdma-assisted-therapy-studies-push-back-on-icers-critical-draft-reportLearn more about our podcast at https://numinusnetwork.com/learn/podcast/Learn more about psychedelic therapy training opportunities at https://numinusnetwork.com/training/Learn more about our clinical trials at https://www.numinusnetwork.com/researchLearn more about Numinus at https://numinusnetwork.com/Email us at [email protected] Follow us on Instagram: https://www.instagram.com/drstevethayer/https://www.instagram.com/innerspacedoctor/https://www.instagram.com/numinushealth/

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