PRESS RELEASE: FDA Agrees to Expanded Access Program for MDMA-Assisted Therapy for PTSD
- Patients to receive early access to treatment outside of Phase 3 trials
- Program will enroll 50 PTSD patients at up to 10 sites in the U.S.
- Expanded Access sites will be announced in the next few months
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Today, the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) announced that the U.S. Food and Drug Administration (FDA) has agreed to MAPS’ application for an Expanded Access program for MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD).
The purpose of the Expanded Access program is to allow early access to potentially beneficial investigational therapies for people facing a serious or life-threatening condition for whom currently available treatments have not worked, and who are unable to participate in Phase 3 clinical trials.
“We commend FDA for recognizing the great unmet medical need of PTSD by allowing access to MDMA-assisted psychotherapy on a compassionate basis for people with treatment-resistant PTSD,” said MAPS Founder and Executive Director Rick Doblin, Ph.D. “We are delighted to begin generating real-world evidence about this potential new treatment.”
On December 20, 2019, the FDA notified MAPS that it may proceed with its Expanded Access protocol, which will allow 50 patients to receive MDMA-assisted psychotherapy following the MAPS treatment protocol (maps.org/treatmentmanual). MAPS hopes to expand the number of patients eligible to receive treatment in the Expanded Access Program. MAPS has proposed to the FDA that after the first 35 patients, it will submit patient data for the agency to consider whether to expand the program.
The Expanded Access protocol differs from MAPS’ ongoing Phase 3 clinical trials in that it is limited to treatment-resistant patients with moderate to severe treatment-resistant PTSD. Other differences are that the FDA is requiring at least one therapist of each therapy pair to have a medical or clinical doctorate degree (M.D., Ph.D., or equivalent), there is no control group, and patients are responsible for the costs of their own treatment.
Up to 10 qualifying treatment sites will be selected to begin the Expanded Access program, to be announced in the next few months. Over 120 site applications have been received to date. Once the program begins, patients can apply to the individual Expanded Access sites. More about Expanded Access site requirements is available here.
“The resurgence of research into using drugs such as MDMA to catalyze psychotherapy is the most promising and exciting development I’ve seen in my psychiatric career,” said Michael Mithoefer, M.D., Acting Medical Director for MAPS Public Benefit Corporation. “Combining the powerful effects of pharmacology with the potential depth of psychotherapy is a compelling model for harnessing advances in neuroscience and psychopharmacology without ignoring the complexity, richness and innate capacity of the human psyche. I’m delighted that the Expanded Access Program will now allow some patients to access to this modality as MAPS’ Phase 3 research continues.”
MAPS’ Expanded Access protocol must still be approved by the U.S. Drug Enforcement Administration (DEA) and the Institutional Review Board (IRB). Based on the FDA’s review as well as the DEA and IRB’s existing support of MDMA-assisted psychotherapy clinical trials, MAPS does not anticipate delays in those approvals.
This is the second time that a government agency has allowed such a program for MDMA-assisted psychotherapy. On February 3, 2019, the Israeli Ministry of Health announced the approval of Compassionate Use for MDMA-assisted psychotherapy for PTSD, which will also allow 50 patients to receive the treatment. Patients with PTSD will be eligible to receive treatment at four sites throughout Israel.
MAPS is currently sponsoring ongoing Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD at 15 sites in the U.S., Canada, and Israel. In August 2017, the FDA granted Breakthrough Therapy Designation to MDMA-assisted psychotherapy for PTSD. The Phase 3 trials are expected to be completed in 2021, meaning that the FDA could approve the treatment as early as 2022. MAPS is also initiating Phase 2 trials in Europe, starting this month.
About MDMA-Assisted Therapy for PTSD
MDMA-assisted psychotherapy uses MDMA to improve the effectiveness of psychotherapy for PTSD. The treatment involves up to three administrations of MDMA in conjunction with psychotherapy in a controlled clinical setting as part of a course of psychotherapy. Once approved, patients will not be able to take the MDMA home—patients won’t be filling their prescriptions at their local pharmacy. Instead, MDMA-assisted psychotherapy treatment will only be available through a doctor and only in supervised therapeutic settings from certified clinicians.
About MAPS
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. Since its founding, MAPS has raised over $70 million for psychedelic therapy and medical marijuana research and education. For more information, visit maps.org.
MAPS-sponsored clinical trials are conducted by the MAPS Public Benefit Corporation (MPBC), a wholly owned subsidiary of MAPS formed in 2014 for the special purpose of balancing social benefits with income from legal sales of MDMA, other psychedelics, and marijuana. For more information, visit mapsbcorp.com.
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