Where is MDMA-Assisted Psychotherapy Legal?

Many people struggling with emotional distress are finding relief in the MDMA experience. Clinical trials on MDMA-assisted psychotherapy have also been promising. Thus far, the results show the treatment to be safe and effective in the treatment of PTSD. (Despite its efficacy for many patients, clinical trials have also faced criticisms related to unethical conduct and unreliable data.)

“This is an exciting frontier, and California will be on the front end of leading it.”

— Gavin Newsom, Governor of California

MDMA therapy for PTSD was granted ‘breakthrough designation’ by the FDA in 2017, which has helped to fast-track its approval. Lykos Therapeutics (formerly MAPS PBC) applied to the FDA earlier this year to approve the treatment. However, a group of researchers have raised concerns about this application.

Despite ongoing debates about the quality of research and ethical issues, authorities have already legalized MDMA-assisted psychotherapy. It could also be approved by the FDA and legalized in other countries in the near future.

Legalized MDMA-Assisted Psychotherapy in Australia

Australia Legalizes MDMA Therapy

On 1 July 2023, Australia legalized MDMA-assisted psychotherapy for the treatment of PTSD. It became the first country in the world to legalize this form of therapy. On this date, psychiatrists also gained the ability to prescribe psilocybin for treatment-resistant depression. For these specific uses, the Poisons Standard listed MDMA and psilocybin as Schedule 8 drugs.

There are requirements for psychiatrists in order to prescribe MDMA (or psilocybin). A psychiatrist must be an Authorized Prescriber (AP) under the Therapeutic Goods Administration’s (TGA’s) Authorized Prescriber scheme. The controls under the AP scheme aim to ensure the safe and effective use of MDMA. Psychiatrists who want to prescribe MDMA also need to show they have adequate training, competency, and research-informed protocols that minimize risks to patients.

Psychiatrists must also conduct an essential assessment before prescribing MDMA to patients. They must assess whether they think the benefits of the treatment outweigh the risks for the PTSD patient in question. The Royal Australian and New Zealand College of Psychiatrists (RANZCP) has created guidance for psychiatrists. These are for how they can prevent adverse events occurring in legalized MDMA-assisted psychotherapy. This guidance will undergo review and updating as the research on MDMA therapy evolves.

Concerns Raised

Despite the safety measures in place, medical experts voiced concerns about the rushed nature of MDMA therapy’s legalization in Australia. For example, Dr. Paul Liknaitzky, Head of Clinical Psychedelic Research at Monash University, said the following after the approval:

“I lead one of only a few sites in Australia that is already delivering psychedelic-assisted therapies to clinical patients. We have witnessed up close the potential of our treatment to change people’s lives for the better. Yet the safety and effectiveness of psychedelic therapies depends on a unique set of professional competencies and considerations that are in scarce supply within mental healthcare. For clinical psychedelic services to be sensible, safe, and useful, considerable professional and public education will be needed, and questions of affordability, eligibility, oversight, and standards of care should be addressed. With this schedule change coming in a matter of months, Australia has very little time to get across this.”

Nonetheless, in January this year, Australian doctor Dr. Ted Cassidy made history by writing the world’s first prescription for MDMA. This prescription was for a patient struggling with severe PTSD. He stated that a single MDMA therapy session could achieve more than conventional treatments can accomplish in a year.

Utah Legalizes MDMA-Assisted Psychotherapy

Bipartisan Support for MDMA Therapy

MDMA, including in a therapeutic context, is still illegal on a federal level in the US. However, in Utah, patients can now access MDMA therapy, although its access is quite limited. Senator Kirk Cullimore introduced Senate Bill 266. It permits two healthcare providers – Intermountain Health and the University of Utah Health – to offer MDMA and psilocybin therapy. Patients must be at least 18 years old to be eligible for treatment. The treatment also has to be supervised by licensed hospital staff. Ismail Ali, policy and advocacy director at MAPS, told Filter:

“This is one of the clearer examples of bipartisan or ‘multi-partisan’ [support] of this work. The fact a bill like this could pass through a majority-Republican legislature, especially with the ease that it did and a tremendous amount of support, demonstrates that the issue itself of access to care in regulated settings does transcend the political binary.”

Accessing MDMA Therapy in Utah May Be Difficult

The bill prevents smaller hospitals and healthcare facilities from providing the treatment. The program is limited to either a privately owned, non-profit healthcare facility with at least 15 licensed hospitals in the state or one affiliated with a higher education institution. Moreover, approved healthcare systems can only use MDMA in the context that has reached Phase 3 clinical trials. This phase is the final step before FDA approval. Only MDMA therapy for PTSD currently meets this standard.

However, some are skeptical that hospital systems that are eligible to offer the treatment will actually do so. Dr. Mason Marks, a law professor at Florida State University specializing in psychedelic law,  told Filter:

“Either of these settings will be very hesitant to get involved in this in any way other than through research or just waiting for FDA approval,” he said. “Unless there’s some actors in Utah that are excited and ready to jump into this, it seems like any licensed health care facility will be hesitant … unless it’s through existing federal regulatory channels.”

Bill Passed in California Allows Patients to Access MDMA Therapy

The Senate Business, Professions, and Economic Development Committee in California passed Senator Scott Wiener’s bipartisan Senate Bill (SB) 1012. It made this decision in April this year. This legislation allows adults 21 and older to use psychedelics and MDMA under the supervision of a trained, licensed professional. Eligible healthcare professionals include psychiatrists, clinical social workers, drug and alcohol counselors, and nurses.

California Governor Gavin Newsom previously vetoed SB 58, which would have decriminalized the personal possession and use of certain psychedelics. Newsom shared a message explaining this veto decision. In it, he asked the Legislature to send him a bill that established guidelines on the therapeutic application of psychedelics. He said:

“Both peer-reviewed science and powerful personal anecdotes lead me to support new opportunities to address mental health through psychedelic medicines like those addressed in this bill. Psychedelics have proven to relieve people suffering from certain conditions such as depression, PTSD, traumatic brain injury, and other addictive personality traits. This is an exciting frontier, and California will be on the front end of leading it…I urge the legislature to send me legislation next year that includes therapeutic guidelines.”

This latest bill, SB 1012, is a response to this request. However, in May 2024, the SB 1012 bill was halted due to “unknown significant ongoing costs” and placed on the ‘suspense file’ without much hope of moving forward with the current state of the California budget.

Pending FDA Approval

On 9 February this year, the FDA accepted Lykos’ New Drug Application (NDA) for MDMA-assisted therapy. The Institute for Clinical and Economic Review (ICER) is a nonprofit dedicated to improving the accessibility and affordability of health treatments. In March, it published its draft evidence report on MDMA therapy for PTSD. In short, ICER is skeptical about the quality of evidence provided by Lykos Therapeutics in its NDA. Their concerns include trial design, conduct issues, and potential safety and ethical problems.

One notable trial design issue exists. In placebo-controlled trials, subjects who receive MDMA clearly know they’ve taken the drug and not a placebo. Because of the effects of MDMA, the trials are essentially unblinded, which affects the reliability of the data.

Lykos announced that the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) will review the evidence in Lykos’ NDA on 4 June. This meeting will mark the first FDA advisory committee review of a new PTSD treatment in 25 years. The research under review includes two Phase 3 clinical trials, which were sponsored and run by MAPS. As part of an open public hearing (OPH), interested persons can present their views in person or in writing.

The outcome of this review will be taken into account during the FDA’s decision-making process around MDMA therapy for PTSD. Lykos expects the FDA to make its decision by August 11, 2024. If approved, the treatment would be legal across the US.