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Lykos’ MDMA Heads To AdComm With US FDA Concerns About Adverse Event Reporting

 
• By Bridget Silverman

‘Short-term effects of midomafetamine were not captured’ in the clinical program for post-traumatic stress disorder, FDA notes. Proposed REMS for the psychedelic therapy to be discussed at 4 June would limit dispensing setting, restrict post-treatment driving.

head shape with PTSD
• Source: Shutterstock

A difference in approach to the classification of subjective effects of psychedelic drugs as adverse events has complicated the already complex balance of safety and efficacy that the US FDA must work through in its review of Lykos’ MDMA candidate for post-traumatic stress disorder (PTSD).

The agency’s Psychopharmacologic Advisory Committee will review Lykos’ midomafetamine NDA on 4 June 2024. The psychedelic therapy, administered with manualized psychological support, has an 11 August user fee goal for...

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