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

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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/

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175 episoade

Artwork
iconDistribuie
 
Manage episode 425579202 series 2943386
Content provided by Numinus. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Numinus or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ro.player.fm/legal.

Send us a text

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/

  continue reading

175 episoade

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