…confirmatory phase 3…
MDMA will be either approved or rejected as a legal prescription medicine.
…positive results from… a multi-site Phase 3 study of MDMA-assisted therapy for post-traumatic stress disorder (“PTSD”). The study met both the primary endpoint as measured by the change from baseline in Clinician-Administered PTSD Scale for DSM-5 (“CAPS-5”) and the key secondary endpoint of improvement in functional impairment associated with PTSD as measured by the change from baseline in the Sheehan Disability Scale (“SDS”). No serious adverse events were observed in either the MDMA group or the control group.
Original Article (Filter Mag & Business Insider):
The cannabis and psychedelics reforms to watch for in 2023 & MAPS PBC announces positive results from confirmatory phase 3 “MAPP2” trial of MDMA-assisted therapy for treatment of PTSD
Artwork Fair Use: Douglas Goldman