Could MDMA Revolutionize PTSD Treatment? In Historic Move, FDA Considers New Drug Application

The for-profit arm of the legendary Multidisciplinary Association for Psychedelic Studies, MAPS Public Benefit Corporation (MAPS PBC), has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for MDMA (midomafetamine capsules) paired with psychological intervention for the potential treatment of PTSD. If approved, it would become the first federally legal psychedelic-assisted therapy.

The filing marks the first New Drug Application (NDA) to the Food and Drug Administration (FDA) for MDMA paired with psychological intervention for the potential treatment of PTSD. If approved, it would become the first federally legal psychedelic-assisted therapy. 

Amy Emerson, MAPS Public Benefit Corporation (MAPS PBC) CEO said the NDA filing “is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades."

With the FDA’s breakthrough therapy designation granted to MDMA in 2017, MAPS PBC requested that the agency grant the NDA a Priority Review. 

The FDA has 60 days to determine whether the application will be accepted for review and whether it will be a priority or standard review (six or ten months, respectively). 

If approved by the FDA, the Drug Enforcement Agency (DEA) would be required to reschedule MDMA, making it available for prescription medical use. 

Also, if approved, the legalization of MDMA-assisted therapy will hopefully drive additional investment into more mental health research.

See Also: Can Psychedelics Therapy Be Reimbursed? AMA Releases Details On Coding These Procedures

MDMA-Assisted Psychotherapy

This type of therapy is an investigational treatment being studied using a combination of MDMA, psychotherapy and other supportive services to treat PTSD. 

MAPS PBC completed a total of six Phase 2 and two Phase 3 studies on MDMA-assisted therapy for PTSD. 

The acute treatment consisted of three treatment cycles over twelve weeks. Each cycle held one medication and three integration sessions. During the medication sessions, patients self-administered MDMA with the supervision of at least one qualified healthcare provider, who provided psychotherapy and other supportive services. Three integration psychotherapy sessions followed this. Before the 12 weeks came three preparatory sessions.

The new NDA submission includes results from these studies as well as two randomized, double-blind, placebo-controlled Phase 3 trials (MAPP1 and MAPP2) evaluating the efficacy and safety of MDMA-assisted therapy with therapy in participants diagnosed with moderate, or moderate and severe PTSD. 

Both MAPP1 and MAPP2 studies met their primary and secondary endpoints and were published in the Nature Medicine journal. There were no serious adverse events reported in the MDMA groups in both studies.

MDMA-assisted therapy has never been approved by any regulatory agencies. The safety and efficacy of MDMA-assisted therapy have not yet been established for the treatment of PTSD. The treatment is also being studied in other indications.

Background

In the 1960's and 1970's MDMA was used with psychotherapy by mental health providers to enhance patients' ability to process difficult emotions and experiences. In 1985, the DEA made it a Schedule I drug, preventing it from being used for medical use. In the 2000s researchers began conducting placebo-controlled studies examining the therapy’s safety and efficacy data for treatment-resistant PTSD.

Photo: Benzinga edit with photo by Yuriy Golub and Bacsica on Shutterstock.