July 20, 2024

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First FDA-approved psychedelic drug could come as soon as 2024

When you think of psychedelic drugs, you may think of the past: 1960s counterculture, the Beatles, neon lava lamps. But some healthcare experts believe psychedelics are the future.

Psychedelics have the potential to transform mental health care, providing treatment options for a range of complex disorders, from treatment-resistant depression to substance use disorder and post-traumatic stress disorder (PTSD). And the first FDA approval of a psychedelic drug could come as soon as 2024.

MAPS Public Benefit Corporation (MAPS PBC), a prescription psychedelics research company founded in 2014, plans to submit an application for its MDMA therapy to the FDA by the end of this year, Amy Emerson, the company’s CEO, told Healthcare Brew. The therapy is designed to treat the roughly 13 million US adults with PTSD.

MAPS PBC is a subsidiary of the nonprofit Multidisciplinary Association for Psychedelic Studies. Its MDMA therapy, if approved, would be the first new FDA-approved PTSD treatment in more than 20 years.

“Given the urgent need for novel, effective treatment options for PTSD and with consistent results from two positive Phase 3 trials, we are hopeful that MDMA-assisted therapy, if approved by the FDA, could be a new option for patients, providers, and therapists to consider,” Emerson said in a statement.

How does MDMA therapy work?

Patients would receive MAPS PBC’s MDMA therapy in addition to three eight-hour therapy sessions spaced three to five weeks apart and 12 drug-free therapy sessions.

MDMA decreases the brain’s fear response, which allows patients “to access and process painful memories without being overwhelmed,” Emerson said. The psychedelic also boosts the release of oxytocin and prolactin, two hormones associated with trust and bonding, according to MAPS PBC.

The company conducted two Phase 3 clinical trials for its MDMA therapy, the first in 2021, both of which showed that patients had “clinically significant improvements” in PTSD symptoms after receiving the treatment.

The results of the second Phase 3 trial, published on September 14 in Nature Medicine, showed that 71.2% of participants receiving the MDMA therapy no longer met diagnostic criteria for PTSD at the end of the study.

In both trials, no serious adverse events were reported. The most frequently reported side effects were “mild or moderate in severity,” including muscle tightness, nausea, decreased appetite, and excessive sweating, according to MAPS PBC.

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While the company has only tested its MDMA therapy for PTSD treatment so far, Emerson said it “intend[s] to consider researching other indications.”

The pathway to approval

Once MAPS PBC submits its application for MDMA therapy to the FDA, the pathway to approval is a bit more complicated than a simple yes or no from the agency, Emerson said.

First, the FDA has 60 days to decide whether to even accept the application. Then, if the application is accepted, the FDA must decide whether to grant it an expedited review.

If expedited review is granted, the FDA has six months to review the application and approve or reject the drug. If the FDA decides not to grant an expedited review, the time period is 10 months, Emerson said.

The FDA could also opt to hold an advisory committee meeting before making a final decision, she added. Advisory committees are made up of scientists, researchers, and other professionals who give FDA officials independent advice on regulatory decisions, like approving a drug or vaccine.

Emerson said MAPS PBC anticipates the FDA will hold an advisory committee meeting before making a decision on the MDMA therapy.

If MAPS PBC meets its end-of-year deadline to submit the application, that means an approval decision would come sometime in 2024.

In May 2022, Miriam Delphin-Rittmon, assistant secretary for mental health and substance use, said the administration expects the FDA to approve MDMA therapy for PTSD treatment within two years, The Intercept reported.

Preparing for approval

The healthcare industry is preparing for FDA-approved psychedelic therapies to become a reality. In May, the American Medical Association approved a current procedural terminology (CPT) III code for psychedelic therapies, paving the way for providers to receive compensation when prescribing psychedelics.

CPT codes are used in electronic health records to track medical services and procedures for reimbursement, and CPT III codes track new, emerging treatments that haven’t yet received FDA approval.

“The development of these new codes highlights the potential role in mental health care that MDMA-assisted therapy may play in the future if approved by the FDA,” Emerson said in a statement. “Given mental health treatments have historically not been reimbursed adequately, it is great to see a new potential avenue for insurance coverage and reimbursement.”