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MDMA-Assisted Therapy for PTSD Delivers Positive Results in MAPS PBC Study
MAPS Public Benefit Corporation (MAPS PBC), a subsidiary of the Multidisciplinary Association for Psychedelic Studies, has announced that MAPP2, its multisite Phase 3 study of MDMA-assisted therapy for post-traumatic stress disorder (PTSD) has met pre-specified primary and key secondary endpoints. The findings clear the way for MAPS PBC to file a new drug application later this year.
Results were measured by the change in baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). No serious adverse events were observed in either the study’s MDMA group or its control group.
MDMA-assisted therapy was granted breakthrough therapy designation by the Food and Drug Administration in 2017. The randomized, double-blind, multisite MAPP2 study explored the efficacy and safety of MDMA-assisted therapy to treat PTSD. The study enrolled 121 participants, 104 of whom were randomized into 1 of 2 segments:
- A group that received 80 to 120 mg MDMA hydrochloride, followed by a supplemental half-dose of 40 or 60 mg during 3 extended therapy sessions;
- A group that received a placebo plus extended therapy sessions
The 12-week study’s participants reflected the demographics of those in the US who are living with PTSD, with people of color representing more than half the study population.
In a news release announcing the findings, MAPS PBC said the organization plans to submit full data from the study for publication in a peer-reviewed journal. CEO Amy Emerson said MAPS PBC plans to file a new drug application later this year.
“The Phase 3 confirmatory results support the development of MDMA-assisted therapy as a potentially new breakthrough therapy to treat individuals with PTSD—a patient population that is often left to suffer for years,” Emerson said. “Now with 2 positive Phase 3 trials complete, we can add this important data to the new drug application which we expect to submit in the third quarter of this year.”
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