FDA, page-4

MDMA-assisted therapy for PTSD has been a topic of intense research and debate in recent years. Initial research on MDMA for PTSD began in the early 2000s, with promising results from small-scale trials. Between 2004 and 2017, six Phase 2 trials were conducted, showing significant reductions in PTSD symptoms among participants receiving MDMA-assisted therapy. Two Phase 3 trials, completed in 2021 and 2022, demonstrated that 67-71% of participants experienced post-traumatic growth, no longer met PTSD diagnostic criteria after three MDMA-assisted therapy sessions, compared to 32-48% in the placebo groups. Then, an observational follow-up study suggested that the treatment’s effects may last for at least six months.

Here’s a list of major studies on MDMA for PTSD and their key findings:

• MAPS Phase 2 Trials (2004-2017):
  Six Phase 2 trials were conducted, showing significant reductions in PTSD symptoms among participants receiving MDMA-assisted therapy.
• MAPS Phase 3 MAPP1 Trial (2021):
  This randomized, double-blind, placebo-controlled study found that 67% of participants who received MDMA-assisted therapy no longer met PTSD diagnostic criteria after three sessions, compared to 32% in the placebo group.
• MAPS Phase 3 MAPP2 Trial (2023):
  This confirmatory study replicated the MAPP1 results, with 71.2% of participants no longer meeting PTSD criteria after MDMA-assisted therapy. The study also demonstrated efficacy across a diverse population, including those with comorbidities.
• Long-term follow-up study (2023):
  An observational study suggested that the treatment effects of MDMA-assisted therapy for PTSD may last for at least six months.
• MPLONG safety studies:
  Multiple ongoing studies have shown that MDMA has been administered to approximately 1,700 human subjects with only one serious adverse reaction reported.