MDMA, 3,4-Methyl enedioxy methamphetamine—commonly known as ecstasy or Molly—could be used to treat certain cases of posttraumatic stress disorder (PTSD) in the future.
The Multidisciplinary Association for Psychedelic Studies (MAPS) said FDA has agreed to its application for an Expanded Access program for MDMA-assisted psychotherapy to treat PTSD.
“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,” says Michael Mithoefer, MD, 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.”
The Expanded Access program would allow early access to “potential 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,” MAPS says in a statement.
“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,” says MAPS Founder and Executive Director Rick Doblin, PhD. “We are delighted to begin generating real-world evidence about this potential new treatment.”
FDA notified MAPS in late December that it may proceed with its Expanded Access protocol, which will allow 50 patients to receive MDMA-assisted psychotherapy following the MAPS treatment protocol.
However, MAPS’ Expanded Access protocol must still be approved by the 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,” MAPS says.
In 2017, FDA granted Breakthrough Therapy Designation to MDMA-assisted psychotherapy for PTSD. As a result, 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.
“The Phase 3 trials are expected to be completed in 2021, meaning that the FDA could approve the treatment as early as 2022,” according to MAPS.
While MAPS has ongoing Phase 3 clinical trials, the Expanded Access protocol would be 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 (MD, PhD, 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, and those will be announced in the next few months, MAPS says.
This is the second time that a government agency has allowed such a program for MDMA-assisted psychotherapy. Last February, 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, according to MAPS.
Patients with PTSD will be eligible to receive treatment at four sites throughout Israel.