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FDA Advisory Committee votes ‘No’ on MAPS/Lykos MDMA-assisted therapy approval
Manage episode 425579202 series 2943386
In 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-report
Learn more about our podcast at https://numinus.com/podcast/
Learn more about psychedelic therapy training opportunities at https://numinus.com/training/
Learn more about our clinical trials at https://www.numinus.com/clinical-trials
Learn more about Numinus at https://numinus.com/
Email us at ptfpodcast@numinus.com
Follow us on Instagram:
https://www.instagram.com/drstevethayer/
https://www.instagram.com/innerspacedoctor/
https://www.instagram.com/numinushealth/
175 episoade
Manage episode 425579202 series 2943386
In 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-report
Learn more about our podcast at https://numinus.com/podcast/
Learn more about psychedelic therapy training opportunities at https://numinus.com/training/
Learn more about our clinical trials at https://www.numinus.com/clinical-trials
Learn more about Numinus at https://numinus.com/
Email us at ptfpodcast@numinus.com
Follow us on Instagram:
https://www.instagram.com/drstevethayer/
https://www.instagram.com/innerspacedoctor/
https://www.instagram.com/numinushealth/
175 episoade
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