Therapy Component Trips Up Lykos’ MDMA At US FDA AdComm For PTSD

Functional unblinding and vague psychotherapy guidance lead to two negative votes for Lykos’ pioneering psychotherapy-assisted psychedelic therapy at the US FDA’s Psychopharmacologic Drugs Advisory Committee.

Lykos’ midomafetamine NDA for post-traumatic stress disorder is pathbreaking on multiple fronts as the first psychedelic therapy to seek US Food and Drug Administration approval with the first psychotherapy-assisted drug indication. But concerns about the functional unblinding inherent in psychedelic use and frustration with the therapy component led the agency’s Psychopharmacologic Drugs Advisory Committee to overwhelmingly turn down the application on 4 June.

Midomafetamine, Lykos’ version of the long-used illicit drug MDMA, is being considered for an indication as an “entactogen,” a psychoactive...