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Second Phase 3 Study of MDMA-Assisted Therapy for PTSD Confirms Findings
A Phase 3 study of MDMA-assisted therapy for post-traumatic stress disorder (PTSD) met its primary and secondary endpoints and confirmed findings from a first Phase 3 study, MAPS Public Benefit Corporation announced this month.
The findings, which were published in the journal Nature Medicine, keep the company on track to submit a new drug application to the Food and Drug Administration (FDA) by the end of 2023.
“With 2 positive Phase 3 studies published, we are focused on pulling all of the data together to submit the new drug application for MDMA-assisted therapy to the FDA later this year,” MAPS PBC CEO Amy Emerson said in a news release. “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.”
If MDMA-assisted therapy for PTSD receives FDA approval, the Drug Enforcement Administration would reschedule MDMA to make it available for prescription medical use.
The second Phase 3 study conducted by MAPS PBC was randomized, double-blind, and placebo-controlled and designed to assess the efficacy and safety of MDMA-assisted therapy compared to placebo with therapy in participants diagnosed with moderate or severe PTSD. The study enrolled 121 adult participants who met full DSM-5 criteria for PTSD and had a CAPS-5 (Clinician-Administered PTSD Scale for DSM-5) total severity score of at least 28 and symptom duration of at least 6 months.
Of the total number of participants enrolled, 104 were randomized into one of the following groups:
- A group that received a split dose separated by 1½ to 2 hours of 80 or 120 mg MDMA hydrochloride followed by 40 or 60 mg during 3 therapy sessions; or
- A group that received a placebo plus extended therapy sessions.
Most participants had a comorbid psychiatric disorder and PTSD for an average of 16 years. The average CAPS-5 score at baseline was 39.0 and was similar between groups. Of the 104 total participants, 28 had moderate PTSD and 76 had severe PTSD. Study outcomes were based on a comparison of assessments at baseline and a primary endpoint of 18 weeks post-baseline visit.
MAPS PBC researchers found that MDMA-assisted therapy significantly reduced PTSD symptoms compared to the effect produced by placebo plus therapy as measured by a reduction in CAPS-5 total severity score. 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.
The study also produced the following exploratory outcomes:
- 86.5% of MDMA-assisted therapy participants experienced clinically meaningful improvement after 18 weeks (defined as a CAPS-5 score reduction of at least 10 points) compared to 69% of the placebo group.
- 71.2% of MDMA-assisted therapy participants no longer met the DSM-5 criteria for PTSD compared to 47.6% of the placebo group.
- 46.2% of the MDMA-assisted therapy group met remission criteria vs. 21.4% of the placebo group.
Consistent with MAPS PBC’s first Phase 3 study, the second Phase 3 study produced no new major safety issues and no reports of MDMA abuse or dependence, including among participants with histories of (or current) mild or moderate alcohol and substance use disorders. Common adverse events reported, including muscle tightness, nausea, decreased appetite, and hyperhidrosis, were similar to prior studies and consistent with the expected effects of MDMA.
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