First-ever drug application for MDMA finally reaches FDA after near 40-year journey

Figuring out how long it's taken the Multidisciplinary Association for Psychedelic Studies' (MAPS) application to reach the FDA’s desk all depends on when you start counting.

The organization was founded by Rick Doblin, Ph.D., in 1986 but didn't start its first clinical trial testing MDMA in patients with post-traumatic stress disorder (PTSD) until 2004. MAPS Public Benefit Organization, a sister organization focused on FDA approval, launched in 2014. Nonetheless, the moment has finally arrived.

MAPS PBC technically submitted its application late Monday, though the announcement came through on Tuesday. It’s the first new drug submission of a psychedelic-assisted therapy and marks a groundbreaking moment in the field of psychedelic research that has for decades tried to rebuild its reputation from hippy experimentation to therapeutic benefit. 

MAPS' application largely centers around two phase 3 studies showing that patients receiving three doses of MDMA bested placebo at reducing symptoms of PTSD as measured by a severity score. The more recent of the two studies found that treated patients had a 23.7-point drop in their CAPS-5 score compared to 14.8 points for patients given placebo. Nearly half of treated patients met the criteria for remission after the third dose, compared to 21.4% of patients on placebo.

Early follow-up data showed that treated patients had durable improvements in symptom severity at least six months after the third dose and more detailed findings are expected to be published in a medical journal in the first quarter of 2024, MAPS PBC CEO Amy Emerson told Fierce Biotech in an interview.

And while the official submission marks a significant milestone for the company, more work awaits in the new year. Emerson expects the application will be accepted sometime around February, which will spur inspections and audits. If the organization is granted a priority review, then the deadline for an FDA decision would likely be sometime around August.

Should the application be approved, MAPS would work with regulators to change the classification of MDMA, currently listed as a scheduling 1 drug, meaning it has no medical use and a high risk of abuse. Emerson said there’s usually a three-month window between approval and rescheduling. 

“The end of one chapter—hitting the send button—is just the opening of a next chapter,” she said. “The time to get an intense amount of work done just gets shorter and shorter.” 

Emerson and her team have already been lobbying states in preparation for approval, knowing that reclassification at the federal level won’t immediately translate to every jurisdiction. California Governor Gavin Newsom recently signed a bill authorizing doctors to prescribe MDMA and psilocybin once they’re rescheduled.

“Once this is approved, I think there's going to be a pressure of people wanting to know when it's available,” she said. 

The sum total of this preparation means that working with regulators and preparing for a successful rollout remain the top priorities for Emerson and MAPS PBC. But submission for PTSD naturally raises questions about where the organization next wants to take the drug. Emerson said the focus will be on other trauma-based disorders, like eating disorders. 

“There's not a lot of treatments available that work well for eating disorders and it disproportionately affects women,” she said. “So that would be an area we'd look.”