MAPS Public Benefit Corporation (MAPS PBC), in a groundbreaking move for psychedelic-assisted therapy, announced their submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration for use of MDMA (midomafetamine capsules) for treating post-traumatic stress disorder (PTSD). This NDA marks a first of its kind submission from any psychedelic-assisted therapy and represents over three decades of extensive clinical research efforts.

MDMA-assisted therapy (MAT), which combines MDMA with psychotherapy and supportive services, has been proposed as an innovative treatment option for adults suffering from posttraumatic stress disorder (PTSD). According to MAPS PBC CEO Amy Emerson, this filing represents a breakthrough in mental health care; providing innovative care to a patient group which has seen limited advancement in recent years.

This groundbreaking submission is supported by two successful Phase 3 trials, MAPP1 and MAPP2, both of which met their primary and secondary endpoints and were published in Nature Medicine as evidence of MDMA-assisted therapy’s efficacy and safety against placebo; marking a major advancement in this field.

MAPS PBC submitted MDMA for Breakthrough Therapy designation by the FDA in 2017, and requested Priority Review; if accepted by them, this would expedite their decision-making process and may shorten timelines to approval.

MAPP1 and MAPP2 Phase 3 studies both demonstrated significant improvements in both symptoms of posttraumatic stress disorder (PTSD), measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), as well as functional impairment related to PTSD as measured using Sheehan Disability Scale (SDS). No serious adverse events were reported amongst MDMA groups in either study.

While MDMA-assisted therapy has yet to receive regulatory approval, its safety and efficacy are being thoroughly analyzed by multiple authorities. Furthermore, this treatment could potentially be utilized for other indications than just PTSD.

MDMA-assisted therapy utilizes both MDMA administration and psychotherapy services, in combination with other supportive services. Treatment typically consists of three cycles over twelve weeks involving one medication session followed by three integration sessions of psychotherapy; this approach builds on MDMA’s historical use in psychotherapy prior to its classification as a Schedule I drug in 1985.

PTSD affects nearly 13 million Americans every year and presents a substantial mental health challenge with current treatments offering limited efficacy. High rates of treatment discontinuation highlight the urgency for novel therapies like MDMA-assisted therapy to provide relief.

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