The FDA Has Labeled ‘Ecstacy’ A ‘Breakthrough Therapy’ For PTSD

U.S. Drug Enforcement Agency/Public Domain

This designation will help the drug make a transition from illegal status to pharmaceutical approval.

Last year, the U.S. Food and Drug Administration designated 3,4-methylenedioxymethamphetamine (MDMA), better known as 'ecstasy', as a "breakthrough treatment" for post-traumatic stress disorder (PTSD), sending the drug on its way to pharmaceutical approval.

The Multidisciplinary Association for Psychedelic Studies (MAPS) announced the FDA’s ruling last week, revealing that they can now move forward on two of their upcoming “Phase 3” trials. The goal of these trials is to determine how effectively the drug can be used to treat those suffering from PTSD. The trials will include 200 to 300 participants, and the first trial will begin to accept subjects in 2018.

MAPS has been investigating the potential therapeutic benefits of MDMA since 1986, but the stigma surrounding the drug has hindered progress.

Previous MAPS trials exploring how well MDMA could treat PTSD have yielded favorable results, contributing to the FDA’s aforementioned decision. In the association’s Phase 2 trails, 107 people who had PTSD for an average of 17.8 years were treated using MDMA-assisted psychotherapy. After two months, 61 percent of the participants no longer suffered from PTSD. After a year, that number increased to 68 percent, according to the MAPS press release.

“This is not a big scientific step,” David Nutt, a neuropsychopharmacologist at Imperial College London, explained to Science. “It’s been obvious for 40 years that these drugs are medicines. But it’s a huge step in acceptance.”