MAPS PBC’s Second Phase 3 Study Confirms Efficacy and Safety, Paving the Way for FDA Approval
A Phase 3 study by MAPS Public Benefit Corporation (MAPS PBC) has demonstrated the efficacy and safety of MDMA-assisted therapy for treating post-traumatic stress disorder (PTSD). The study’s positive outcomes could extend treatment options for PTSD, subject to FDA approval.
HCN Medical Memo
The implications of this study could end up being quite profound. If MDMA-assisted therapy gains FDA approval, it could offer a new, effective treatment avenue for PTSD—a condition notoriously difficult to treat. With robust data supporting its efficacy and safety, this could become an important tool in the therapeutic arsenal for physicians, pharmacists, and nurses alike.
- The Phase 3 study met its primary and secondary endpoints, confirming results from a previous Phase 3 study.
- The study was randomized, double-blind, and placebo-controlled, involving 121 adult participants diagnosed with moderate or severe PTSD.
- The MDMA-assisted therapy group saw an average reduction in CAPS-5 score of 23.7 points, compared to 14.8 points for the placebo group.
- MAPS PBC CEO Amy Emerson stated that the company is preparing to submit a new drug application to the FDA by the end of 2023.
- If approved, the Drug Enforcement Administration would reschedule MDMA for prescription medical use.
“Given the urgent need for novel effective treatment options for PTSD and with consistent results from 2 positive Phase 3 trials we are hopeful that MDMA-assisted therapy, if approved by the FDA, could be a new option for patients, providers and therapists to consider.”
– Amy Emerson, MAPS PBC CEO
- 86.5% of participants in the MDMA-assisted therapy group experienced clinically meaningful improvement after 18 weeks, compared to 69% in the placebo group.
- 71.2% of the MDMA group no longer met the DSM-5 criteria for PTSD, compared to 47.6% of the placebo group.
- No new major safety issues were reported, and common adverse events were consistent with the expected effects of MDMA.
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