Sequencer

The FDA may approve psychedelic-assisted therapy for PTSD, but at a recent public hearing it was the therapy — not the drug — that burned in the hot seat.

Yesterday, June 4th, an advisory committee convened to discuss whether to recommend that the US Food and Drug Administration (FDA) approve MDMA psychedelic-assisted therapy for post-traumatic stress disorder (PTSD) when the agency renders a decision this summer. The drug application’s sponsor, Lykos Therapeutics, a biopharma company focusing on mental health treatments, had led two Phase 3 clinical trials combining MDMA with a therapy philosophy allegedly rooted in controversial New Age ideas. The advisory committee invited members of the public to speak. More than 30 individuals shared their testimony in favor or against approval. 

Rather than a straightforward, dusty bureaucratic session, the hearing was eye-opening, puzzling, fascinating, and profoundly sad. 

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