The safety and efficacy of MDMA-assisted therapy is currently under investigation. It is not yet approved by the FDA, does not work for everyone, and carries risks even in therapeutic settings.
PTSD affects millions of people worldwide
13M adults in the U.S. suffer from PTSD during a given year
350M+ people suffer from PTSD worldwide
Sources: U.S. Department of Veterans Affairs, National Center for PTSD
Global Prevalence: https://www.uptodate.com/contents/posttraumatic-stress-disorder-in-adults-epidemiology-pathophysiology-clinical-manifestations-course-assessment-and-diagnosis
PTSD War Population: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6394282/pdf/zept-10-1578637.pdf
MDMA is capable of inducing unique psychopharmacological effects, such as:
- Decreased feelings of fear and defensiveness
- Increased feelings of wellbeing
- Increased sociability and extroversion
- Increased interpersonal trust
- An alert state of consciousness
MAPS recently completed MAPP2, the second of two Phase 3 trials to support FDA approval of this Breakthrough-Designated therapy. With this completion, MDMA-assisted therapy is expected to receive FDA evaluation in 2023.
In our first Phase 3 study, 88% of participants with severe PTSD experienced a clinically significant reduction in PTSD diagnostic scores two months after their third session of MDMA-assisted therapy, compared to 60% of placebo participants.
Additionally, 67% of participants in the MDMA group compared to 32% of participants in the placebo group no longer met the criteria for PTSD two months after the sessions.
Expanded Access Program
Pivotal Phase 3 Program Studies
Veterans Affairs (VA) Studies
How Does MDMA-Assisted Therapy Work?
- MDMA-assisted therapy is delivered during three 8-hour sessions, scheduled three to five weeks apart, along with 12 non-drug therapy sessions to aid with preparation and integration.
- MDMA is a triple reuptake inhibitor that produces anxiolytic and prosocial effects through the release of neurotransmitters such as serotonin, norepinephrine, and dopamine.
- MDMA also increases the release of oxytocin and prolactin (hormones associated with trust and bonding) as well as hormones that influence the HPA axis and stress response.
- MDMA decreases activity in the left amygdala (associated with fear and trauma) which may allow patients to more openly discuss their memories in therapy.