The US Food and Drug Administration has determined that MDMA, also known as ecstasy, is a “breakthrough therapy” for the treatment of post-traumatic stress disorder (PTSD).
The ruling was announced August 26 by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS).
The new “breakthrough therapy” designation means the FDA agrees that the treatment “may have a meaningful advantage and greater compliance over available medications for PTSD.”
Trials of MDMA-assisted psychotherapy for patients with severe PTSD will now move on to Phase 3.
“For the first time ever, psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way,” said Rick Doblin, Founder and Executive Director of MAPS. “Now that we have agreement with FDA, we are ready to start negotiations with the European Medicines Agency.”
According to MAPS, the Phase 3 trials will assess the efficacy and safety of MDMA-assisted psychotherapy in 200-300 participants with PTSD, aged 18 and older, at sites in the U.S., Canada, and Israel. Participants will be randomized to receive three day-long sessions of either MDMA or placebo in conjunction with psychotherapy over a 12-week treatment period, along with 12 associated 90-minute non-drug preparatory and integration sessions.