Zinger Keypoints:

• Long-term (over 1 year) follow-up reflects lasting improvements in symptom severity.

• Data confirms prior Phase 2 studies on MDMA-assisted therapy’s sustained effect on PTSD treatment.

• New Drug Application (NDA) to be submitted in Q3 2023 would be the last step before DEA reschedules the therapy.

The private arm of the legendary Multidisciplinary Association for Psychedelic Studies, MAPS Public Benefit Corporation (MAPS PBC) shared positive topline results from an observational follow-up of its two Phase 3 studies on the long-term safety and efficacy of MDMA-assisted therapy for PTSD. 

The findings show participants held a durable response within at least six months and in some cases a year or more, post-treatment with MDMA-assisted therapy.

"These results are consistent with previously published Phase 2 data demonstrating the sustained effect of MDMA-assisted therapy at least 12 months following treatment and suggest the acute treatment effect could last even longer," said MAPS PBC’s CEO, Amy Emerson.

PTSD is a chronic condition that affects approximately 13 million Americans each year, producing generalized debilitating symptoms and frequently bringing along serious comorbidities such as anxiety, depression, and Substance Use Disorder (SUD.) 

All in all, it costs the health system over $200 billion annually, with currently available treatments being inadequate or insufficient.

Emerson says the condition has historically been addressed through long-term maintenance treatment, “which is why it's important to evaluate whether an acute treatment like MDMA-assisted therapy has an enduring response when used to treat PTSD." 

MDMA And Steps Forward

MDMA, an entactogen or psychoactive drug that induces one to experience emotional communion, oneness, relatedness and openness has a long history within the therapeutic field.

First used during the 1960's and 1970's paired with psychological therapy to enhance patients' access, processing and communication of difficult emotions and experiences, MDMA was made a Schedule I drug in 1985, making recreational and medical use of it illegal. 

Yet research showing MDMA’s enormous potential supporting psychotherapy by helping attenuate the brain's fear response and allowing patients to access and process painful memories without being overwhelmed prevailed. The treatment was finally designated a “Breakthrough Therapy” by the FDA in 2017. 

This has helped the treatment to further develop with the aim of reviewing its legal status and allowing patient access.

With follow-up data still being collected from participants, results are encouraging and MAPS PBC expects to submit a New Drug Application (NDA) to the FDA in the third quarter of 2023. Approval would mean the DEA reschedules MDMA, making it available for medical use.

Benzinga’s Psychedelics Capital Conference

April 13th at the Fontainebleau Miami Beach Hotel will be THE place to set up deals, raise money, meet investors and key partners, and learn from the industry’s greatest.

Get your tickets now and don’t miss out!

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