Psychedleic drugs often bring up images of 1960s counterculture but many healthcare experts see psychedelics are the future for treatment of various mental disorders.
Psychedelics have the potential to transform the approach to mental health care, providing poential treatment options for a range of complex disorders, from treatment-resistant depression to substance use disorder and post-tramatic stress disorder (PTSD). The initial FDA approval of a psychedelic drug could come as soon as 2024.
MAPS Public Benefit Corporation (MAPS PBC), a prescription psychedelics research company, plans to submit an application for MDMA therapy to the FDA by the end of this year. The therapy is designed to treat the roughly 13 million US adults with PTSD.
MAPS PBC is a subsidiary of the nonprofit Multidisciplinary Association for Psychedelic Studies. Its MDMA therapy, if approved, would be the first new FDA-approved PTSD treatment in more than 20 years.
How does MDMA therapy work?
Patients would receive MAPS PBC’s MDMA therapy in addition to three eight-hour therapy sessions spaced three to five weeks apart and 12 drug-free therapy sessions.
MDMA decreases the brain’s fear response, which allows patients to access and process painful memories without being overwhelmed. The psychedelic also boosts the release of oxytocin and prolactin, two hormones associated with trust and bonding, according to MAPS PBC.
The company conducted two Phase 3 clinical trials for its MDMA therapy, the first in 2021, both of which showed that patients had clinically significant improvements in PTSD symptoms after receiving the treatment.
The results of the second Phase 3 trial, published on September 14 in Nature Medicine, showed that 71.2% of participants receiving the MDMA therapy no longer met diagnostic criteria for PTSD at the end of the study.
In both trials, no serious adverse events were reported. The most frequently reported side effects were “mild or moderate in severity,” including muscle tightness, nausea, decreased appetite, and excessive sweating, according to MAPS PBC.