Summary: Psychedelic Health covers the completion of enrollment for our confirmatory Phase 3 trial of MDMA-assisted therapy for PTSD. Per the special protocol agreement negotiated with the U.S. FDA, this second of two Phase 3 trials was designed to enroll at least 100 participants to confirm the efficacy and further investigate the safety of the treatment.
Charlotte Harrison, Associate Director for Pivotal Programs at MAPS Public Benefit Corporation (MAPS PBC), explains the significance of this milestone: “The completion of enrollment brings us one step closer to making this novel treatment available to the many people who were not able to participate and accessible to those who need it most.”
