The U.S. Food and Drug Administration (FDA) has given the go-ahead to the Multidisciplinary Association for Psychedelic Studies (MAPS) to conduct clinical trials of the drug methlyenedioxymethamphetamine — better known as MDMA, or ‘ecstasy’ — for use in the treatment of post-traumatic stress disorder (PTSD).
The FDA granted Breakthrough Therapy Designation status to MDMA because preliminary clinical evidence shows that “this treatment may have a meaningful advantage and greater compliance over available medications for PTSD,” a MAPS statement said, as reported by Forbes.
MAPS is a non-profit organization that has spent about 30 years investigating the medical uses of MDMA. Researchers found the drug helps PTSD sufferers better cope with their residual trauma by, in part, producing feelings of intense happiness and empathy — emotions that are often inaccessible to someone afflicted with PTSD.
According to MAPS, it has agreed with the FDA under a special protocol for the design of two Phase 3 trials for MDMA-assisted psychotherapy for patients with severe PTSD.
“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 MAPS founder and executive director Rick Doblin, in a statement, as reported by Forbes. “Now that we have agreement with FDA, we are ready to start negotiations with the European Medicines Agency.”
The Phase 3 trials, which will be randomized and placebo-controlled, will test the safety and efficacy of MDMA-assisted psychotherapy for a group of 200 to 300 participants with PTSD at sites in the U.S., Canada, and Israel.
Trials could start as early as next spring if MAPS can raise the estimated $25 million required to conduct them.