FDA grants Expanded Access to MDMA for PTSD

The U.S. Food and Drug Administration (FDA) approved on Friday an Expanded Access program application for 3,4-methylenedioxy-methamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder (PTSD), according to an announcement released by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS).

MAPS was formed shortly after MDMA was made illegal in 1985, and since then has dedicated millions of dollars into clinical trials. The organization is in the midst of Phase 3 clinical trials and expects to complete in 2021, with the aim of the FDA approving treatment as early as 2022.

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 the group’s ongoing Phase 3 clinical trials, according to MAPS representatives.

The FDA notified MAPS in December that the group could proceed with its Expand Access protocol, allowing 50 patients to receive to receive MDMA-assisted psychotherapy following the MAPS treatment protocol. With the new approval, MAPS representatives said they hope to expand the number of patients eligible to receive treatment. After the first 35 patients, the group will submit patient data to the FDA 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 (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, 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.

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 leadership said it does not anticipate delays in those approvals.