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