The Food and Drug Administration has determined that illicit drug ecstasy is a “breakthrough therapy” for post-traumatic stress disorder (PTSD) treatment.
Methylenedioxymethamphetamine (MDMA), commonly referred to as ecstasy, could now have a faster pathway to pharmaceutical approval in the US, reports Science Alert.
The Multidisciplinary Association for Psychedelic Studies announced the FDA’s ruling last week, with “Phase 3” trials set to start soon.
The goal of these trials is to determine how effectively the drug treatment can be for those suffering from PTSD.
The PSTD research trials will include 200 to 300 participants, and the first trial will begin to accept subjects in 2018.
“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.
The initial trials will be held in the US, Canada and Israel.