Phase 3 Trials: FDA Grants Breakthrough Therapy Designation for MDMA-Assisted Therapy for PTSD, Agrees on Special Protocol Assessment
MAPS’ highest priority project is sponsoring Food and Drug Administration (FDA) drug development research into 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of posttraumatic stress disorder (PTSD). FDA has designated MDMA-assisted therapy for PTSD a Breakthrough Therapy, and has come to agreement with MAPS on Phase 3 protocol designs after a rigorous Special Protocol Assessment (SPA) process. MAPS’ goal is to develop MDMA-assisted therapy for PTSD into an FDA-approved prescription treatment. The Phase 3 trials are expected to be complete in 2022, meaning that FDA could approve the treatment as soon as 2023. MAPS is also initiating Phase 2 trials in Europe.
We are studying whether MDMA-assisted therapy can help heal the psychological and emotional damage caused by sexual assault, war, violent crime, and other traumas. We also sponsored completed studies of MDMA-assisted therapy for autistic adults with social anxiety, and MDMA-assisted therapy for anxiety related to life-threatening illnesses.
FDA Agrees to Expanded Access Program for MDMA-Assisted Therapy for PTSD
On December 20, 2019, the U.S. Food and Drug Administration (FDA) agreed to MAPS’ application for an expanded access program for MDMA-assisted therapy 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. The program will enroll 50 PTSD patients at up to 10 sites in the U.S. Site locations will be announced in the next few months.
Expanded access is a U.S. FDA program that allows the use of an investigational drug under a Treatment Protocol. The program is designed to address urgent and life-threatening conditions in patients who do not currently have promising treatment options. Only sites within the U.S. and U.S. territories are eligible to participate in the U.S. FDA’s expanded access program. You can learn more about expanded access on the FDA’s website.
New sites meeting the requirements listed below may seek approval to participate in MAPS PBC’s multi-center expanded access protocol under an FDA Treatment IND, which would allow them to administer open-label MDMA-assisted therapy for PTSD in line with the single approved protocol. Qualified applicants will have a team of therapy providers, a physician, and a facility suitable to conduct MDMA-assisted therapy per Schedule I regulations with approval by regulatory agencies and under supervision of MAPS PBC.
We have a online training application for eligible expanded access sites and providers.
Learn about our MDMA Therapy Training Program.
MAPS is undertaking a plan to make MDMA-assisted therapy into a Food and Drug Administration (FDA)-approved prescription treatment by 2023. For-profit pharmaceutical companies are not interested in developing MDMA into a medicine because the patent for MDMA has expired. The idea of using MDMA to assist therapy of any kind for any specific clinical indication has long been in the public domain.
In MDMA-assisted therapy, MDMA is only administered a few times, unlike most medications for mental illnesses which are often taken daily for years, and sometimes forever.
MDMA is not the same as “Ecstasy” or “molly.” Substances sold on the street under these names may contain MDMA, but frequently also contain unknown and/or dangerous adulterants. In laboratory studies, pure MDMA has been proven sufficiently safe for human consumption when taken a limited number of times in moderate doses.
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Learn about MDMA-assisted therapy for social anxiety in autistic adults at mdma-autism.org.
