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Lykos’ MDMA Trial Conduct Allegations Influence US FDA Advisory Committee

 
• By Bridget Silverman

Safety concerns related to MDMA patient suggestibility and impairment troubled the panel reviewing psychedelic therapy for PTSD, although the FDA advised that therapist misconduct is outside its control.

psychotherapy
The FDA does not regulate psychotherapy. • Source: Shutterstock

Advisory committee members could not limit their review of Lykos’ proposed MDMA therapy for post-traumatic stress disorder to issues directly within the US Food and Drug Administration’s control, which could impact the agency’s final decision on the product.

Lykos’ proposed midomafetamine-assisted therapy (MDMA-AT) process poses a “novel treatment paradigm,” where the psychedelic drug is intended to catalyze effective...

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