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...