A company focused on developing novel treatments for mental health this week announced that it has submitted an application to the U.S. Food and Drug Administration seeking the approval of MDMA-assisted therapy. The application, which was submitted by MAPS Public Benefit Corporation (MAPS PBC) after more than three decades of clinical research into the potential use of MDMA-assisted therapy for PTSD, represents a significant achievement in the effort to develop safe and effective mental health therapies utilizing psychedelic drugs.

In 2017, the FDA granted Breakthrough Therapy designation for psychotherapy utilizing MDMA, the psychedelic drug commonly known as Ecstasy, indicating that the therapy is a significant improvement over existing treatments. But so far, MDMA-assisted therapy has not been approved by any regulatory agency as an approved option for mental health treatment. 

MAPS PBC is a subsidiary of the groundbreaking psychedelics nonprofit advocacy group the Multidisciplinary Association for Psychedelic Studies (MAPS), which has been working to develop new psychedelic-based treatments for decades. After reporting promising results from two clinical trials investigating MDMA-assisted therapy as a treatment for post-traumatic stress disorder (PTSD), MAPS PBC announced in January that the company planned to submit the new drug application (NDA) to the FDA in the third quarter of 2023.

“The filing of our NDA 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,” Amy Emerson, CEO of MAPS PBC, said in statement on Tuesday. “If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health.”

Application Based on Decades of Research

The NDA submission included results from numerous studies including two randomized, double-blind, placebo-controlled Phase 3 studies known as MAPP1 and MAPP2, which evaluated the efficacy and safety of MDMA-assisted therapy versus placebo with therapy in participants diagnosed with moderate or moderate and severe PTSD, respectively. Both MAPP1 and MAPP2 studies met their primary and secondary endpoints and were published in the peer-reviewed journal Nature Medicine.

Earlier this year, MAPS PBC reported results from MAPP2, which enrolled 121 participants with PTSD for a 12-week treatment period. The participants recruited for the study reflected the demographics of those living with the disorder in the United States, with people of color representing more than half of those enrolled in the study. 

Of the 121 participants, 104 were randomized to either a group that received 80 to 120 mg MDMA hydrochloride followed by a supplemental half-dose of 40 or 60 mg during three extended sessions of therapy, or a group that received placebo plus extended sessions of therapy. At the end of the study, the research showed significant improvement in PTSD among participants in the MDMA group as measured by commonly used clinical diagnostic scales.

“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 in a statement at the time.

FDA To Review Application

Because of MDMA’s designation as a breakthrough therapy, MAPS PBC has requested that the FDA grant a priority review of the NDA. The FDA has 60 days to determine whether the NDA will be accepted for review and whether it will be a priority or standard review (six months or ten months, respectively). If approved by the FDA, the U.S. Drug Enforcement Administration would be required to reschedule MDMA, making it available for prescription medical use.

Sherry Rais, the co-founder and CEO of Enthea, a licensed, third-party administrator of health insurance benefits working to provide coverage for psychedelic-based therapies as an employee benefit, said that the FDA’s pending review of MDMA-assisted therapy “represents a significant milestone, not just for the healthcare and psychedelic industries, but also for humanity as a whole.”

“Millions of people living with PTSD are hoping to access MDMA-assisted therapy as a safe, effective healing modality,” Rais wrote in an email. “This moment serves as a promising leap toward formally acknowledging this treatment and providing universal access.”

Shawn Hauser, a partner at Vicente LLP and the co-chair of the law firm’s Hemp and Cannabinoids Department, also serves as a leading member of the firm’s Psychedelics and Emerging Therapies practice. She said that the potential FDA approval of MDMA is “hopeful and promising given its incredible therapeutic potential, especially for a country devastated by an opiate crisis.”

“The submission of the first psychedelic-assisted therapy to the FDA for approval, along with the FDA’s recommendation to reclassify cannabis to Schedule III, acknowledging its medical use, highlights a very promising shift in federal drug policy,” Hauser said in a statement to High Times.

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