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Frances Vinall

MAPS Public Benefit Corp. filed an application on Tuesday with the U.S. Food and Drug Administration to approve the psychedelic drug MDMA — also known as Ecstasy — in combination with therapy to treat post-traumatic stress disorder, in what would be the first treatment of its kind.

The filing is a milestone in researchers’ quest to move psychedelic drugs from tightly restricted substances into mainstream medical treatments that are widely accessible to patients. It comes after decades of studies have demonstrated the promise of psychedelics — including psilocybin, or magic mushrooms, and ketamine — to treat mental health disorders.

“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,” Amy Emerson, chief executive of MAPS, said in a <a href="https://mapsbcorp.com/news/mdma-for-ptsd-fda-submission/" target=_blank>statement</a> Tuesday. MAPS is seeking a priority review from the FDA that could yield a determination within six months.

FDA approval, while by no means assured, could raise tricky issues for regulatory authorities. The FDA doesn’t regulate the practice of medicine, which is generally left to state licensing boards. It isn’t yet clear to what extent authorities will address who is authorized to provide therapy and the question of doctors potentially prescribing MDMA for different conditions, known as off-label use.

Emerson said in a September interview that she expected that, if the treatment is approved, an FDA label would say the treatment “needs to be implemented in the way it was studied” — with a therapy component.

If the FDA approves the application, it could impose strict rules around who can prescribe MDMA and what pharmacies or facilities can dispense the drug, said Mason Marks, a senior fellow at the Project on Psychedelics Law and Regulation at Harvard Law School. Facilities could also be required to provide space and supervision for a certain period for a patient taking MDMA, he said.

“I imagine there will be some significant restrictions” imposed by the FDA, said Marks, who also noted the potential for controversy surrounding the drug. “I don’t think it will be a quick turnaround,” Marks said.

To support its application, MAPS conducted two <a href="https://www.nature.com/articles/s41591-021-01336-3" target=_blank>late-stage</a> <a href="https://www.nature.com/articles/s41591-023-02565-4" target=_blank>trials</a> that showed benefits in scales that assess the symptoms of PTSD. The organization said no serious adverse events were reported from subjects who received MDMA in the studies. In conjunction with taking the drug, subjects engaged in psychotherapy — also known as talk therapy — along with other supportive services.

MAPS envisions licensed health-care professionals providing the therapy, which could include those with a range of credentials, Emerson has said. Other experts agree with that notion.

“You need somebody with a license on the line to be accountable for patient safety,” said Dominic Sisti, a professor of medical ethics at the University of Pennsylvania who also consults pro bono for MAPS.

The FDA approved a <a href="https://www.washingtonpost.com/health/2019/03/06/biggest-advance-depression-years-fda-approves-novel-treatment-hardest-cases/" target=_blank>variation of ketamine</a> in 2019 that remains the only psychedelic approved to treat depression. Since then, companies developing psychedelic drugs or services have raised more than $560 million from venture capital firms, according to the data provider PitchBook. MDMA and psilocybin have obtained “breakthrough” status from the FDA, a designation that expedites development for drugs that show “substantial improvement” over available therapies.

Executive behind ChatGPT pushes for a new revolution: Psychedelics

MAPS Public Benefit Corp. is a for-profit arm of the Multidisciplinary Association for Psychedelic Studies, a pioneering nonprofit that has raised more than $130 million since its founding in 1986. The organization has focused its efforts on MDMA, a synthetic compound, to treat PTSD in combination with therapy.

MAPS has faced controversy in the past. A former investigator for a MAPS-sponsored clinical trial acknowledged that he had a sexual relationship with a participant after the trial concluded in 2015, <a href="https://maps.org/2019/05/24/statement-public-announcement-of-ethical-violation-by-former-maps-sponsored-investigators/" target=_blank>according to the organization</a>. MAPS said the investigator and his wife and co-therapist violated its code of ethics and were barred from becoming providers of MDMA-assisted therapy.

MDMA is in the most restrictive category of drugs regulated by the Drug Enforcement Administration, which classifies it as having “no currently accepted medical use” and a high potential for abuse. If the FDA approves MAPS’s application, the DEA would be required to reclassify a version of MDMA so that it could be prescribed to patients.

The FDA has increasingly acknowledged the growing push for psychedelic treatments, publishing <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/psychedelic-drugs-considerations-clinical-investigations" target=_blank>guidance</a> for running clinical trials for such drugs in June. That alone “is a policy landmark and reflects shifting attitudes toward controversial substances,” concluded an <a href="https://www.nejm.org/doi/full/10.1056/NEJMp2308940" target=_blank>opinion piece</a> in the New England Journal of Medicine published last month.

Voters in Oregon <a href="https://www.washingtonpost.com/nation/2020/11/04/election-drugs-oregon-new-jersey/" target=_blank>legalized psilocybin</a> in 2020, and the state has licensed facilities providing such care, while Colorado passed a ballot measure last year that will allow adults to use psilocybin in licensed facilities starting next year. Voters in D.C. <a href="https://www.washingtonpost.com/local/dc-politics/dc-magic-mushrooms-result/2020/11/03/bb929e86-1abc-11eb-bb35-2dcfdab0a345_story.html" target=_blank>decriminalized</a> certain psychedelic drugs in 2020, joining cities including Denver and Oakland, Calif.

MAPS has exclusive rights to the data supporting MDMA, preventing competition from generics for at least five years. Emerson, CEO of the public-benefit subsidiary, has said it will make money on the sale of the drug but not the therapy. The latter will require the creation of a medical code for therapists to bill for their services — which could be expensive.

The treatments in MAPS’s clinical trials consisted of three eight-hour sessions, spaced about a month apart. <a href="https://www.washingtonpost.com/magazine/2020/09/21/psychedelic-medicine-will-it-be-accessible-to-all/" target=_blank>Some estimates</a> have ranged from $13,000 to $15,000 per round of treatment.

Some mental health experts are skeptical about MDMA’s potential. Allen Frances, a Duke University professor emeritus of psychiatry, has criticized the methodology of the studies that led to the new drug application and said few will benefit. “Most people in the world won’t be able to afford these clinics,” he said.

Because of the high price and hype generated by FDA approval, Frances said, people with psychiatric problems will turn to knockoff MDMA bought on the streets. Counterfeit MDMA pills could be unsafe and laced with dangerous drugs such as fentanyl, Frances said.

MAPS is also considering other potential treatments beyond PTSD. “We will be looking at other indications as we go forward where trauma is at the root of the issue,” Emerson said in the September interview. For now, MAPS is focused on getting FDA approval for the PTSD-assisted therapy. “We’re very aware that we’re setting a precedent.”

<i>Laurie McGinley contributed to this report.</i>

University of Chicago, BA in International Studies

Daniel Gilbert joined The Washington Post in 2022 and writes about the business of medicine. He previously spent seven years as an investigative reporter for the Seattle Times, and before that covered business and energy for the Wall Street Journal.

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