Why it matters: MAPS Public Benefit Corporation (MAPS PBC) has submitted an application to the FDA seeking approval for MDMA-assisted therapy, which would be the first psychedelic-assisted therapy if approved. This submission represents a significant achievement in the development of safe and effective mental health therapies using psychedelic drugs.
What they are saying: MAPS PBC’s CEO, Amy Emerson, stated that the submission of the application is the result of over 30 years of research, advocacy, collaboration, and dedication. The Phase 3 studies evaluating MDMA-assisted therapy for PTSD showed significant improvement in participants’ symptoms, supporting the development of this therapy as a breakthrough treatment.
The big picture: The submission of the application for MDMA-assisted therapy is a milestone in the field of mental health and psychedelic research. If approved, it could pave the way for further investment and research in mental health. This comes at a time when the opioid crisis in the United States has devastated many, making the potential approval of MDMA all the more hopeful.
What to watch: The FDA will review the application and decide whether to grant a priority or standard review within 60 days. If approved, MDMA would need to be rescheduled by the Drug Enforcement Administration for prescription medical use. The potential approval of MDMA-assisted therapy could have implications for other psychedelic-based therapies and may signal a shift in federal drug policy.
My take: The submission of the application for MDMA-assisted therapy is an exciting development in the field of mental health and psychedelic research. The promising results from the Phase 3 studies provide hope for individuals living with PTSD. If approved, this therapy could offer a new and potentially more effective treatment option for those who have experienced little innovation in decades. Additionally, it may open the door for further exploration of psychedelic-based therapies and contribute to changes in drug policy.