MAPS Public Benefit Corporation (MAPS PBC), the nonprofit’s clinical-stage private arm, published new data from its second multi-site, ethno-racially diverse Phase 3 clinical study of MDMA-assisted therapy for PTSD in Nature Medicine.
The randomized MAPP2 study gave participants a split dose, separated by 1.5 to 2 hours, of 80 or 120 mg of MDMA hydrochloride (or placebo,) and following a 40 to 60 mg dose during three therapy sessions. The placebo group received extended therapy sessions.
71% of total 104 participants were assigned female sex at birth, constituting 82% of the placebo group and 60% of the MDMA-assisted therapy group. Participants were also ethnically and racially diverse, 34% identifying as other than White, and 27% as Hispanic/Latino.
Most participants had a comorbid psychiatric disorder and had PTSD for an average of 16 years (28 participants in the moderate form, and 76 in the severe form.)
Results reflect the trial met its primary and secondary endpoints:
86.5% (46) of participants in the MDMA-assisted therapy group experienced a significant reduction in PTSD symptoms at 18 weeks post-baseline, versus 69% (35) of total participants (51) receiving placebo with therapy.
71.2% (38) of participants in the MDMA group no longer met DSM-5 diagnostic criteria for PTSD by the study’s end, versus 47.6% (24) of participants in the placebo group.
46.2% of MDMA group participants met remission criteria, compared to 21.4% of the placebo group participants at study termination.
Improvements (including a reduction in clinician-rated functional impairment) were observed across all domains including family, social and work life.
MDMA was generally well tolerated, no serious adverse events were reported. The most common reported effects included mild-to-moderate muscle tightness, nausea, decreased appetite and hyperhidrosis.
No new major safety issues for cardiac function were reported nor MDMA abuse or dependence and, although participants in the MDMA group experienced temporary dose-dependent increases in blood pressure and pulse during drug administration, those were consistent with MDMA’s sympathomimetic effects and did not require clinical intervention.
PTSD-correlated suicidal ideation was observed in both groups, nonetheless, MDMA did not appear to increase this risk. No suicidal behavior was observed.
The peer-reviewed data confirms the results seen in the first Phase 3 trial (MAPP1) published in the journal Nature in 2021, helping validate “the rigor of the data collected” altogether in the pivotal Phase 3 program, says study author Jennifer Mitchell, Ph.D.
And, importantly, it suggests outcomes “may be generalized to a broader population of individuals with PTSD who vary not only in the severity of their symptoms but also in their racial and ethnic backgrounds,” said Mitchell, a professor of neurology and psychiatry & behavioral sciences at UCSF and associate chief of staff for R&D at the San Francisco VA medical center.
MAPS PBC’s CEO, Amy Emerson, says the company is now gathering all the data together to submit the New Drug Application (NDA) for MDMA-assisted therapy to the FDA later this 2023. If granted, the DEA would then reschedule MDMA, and the psychedelic would become available for prescription medical use.
“Given the urgent need for novel effective treatment options for PTSD and with consistent results from two 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,” concluded Emerson.
Photo: Benzinga edit with photo by luchschenF and ANDREI ASKIRKA on Shutterstock.