FDA Labels MDMA a ‘Breakthrough Therapy’ for PTSD

The Multidisciplinary Association for Psychedelic Studies (MAPS) announced the designation of MDMA-Assisted Psychotherapy for PTSD as a “breakthrough therapy” by the FDA.

The roughly eight million sufferers of Post Traumatic Stress Disorder (PTSD) may have new hope, in the form of 3,4-methylenedioxymethamphetamine or MDMA. The drug, commonly known by the street names “molly” or “ecstasy,” will now move into MAPS Phase 3 trials beginning in 2018, on the way to an approval process that may have just become significantly easier.

MAPS Founder and Executive Director Rick Doblin is already moving from one mountain to the next, saying that having reached “agreement with FDA,” the organization is “ready to start negotiations with the European Medicines Agency.”

With $13 million in the bank, MAPS has so far only managed to raise about half of their funding goal for the trials that will taker place in the United States, Canada, and Israel. If all goes well, the aforementioned negotiations with the EMA will expand the scope of the study into Europe.

It has been a long and hard-fought battle. MAPS has been conducting research on Ecstasy and its chemical relatives since 1986. But until the first randomized controlled pilot study was released in 2011, there had been little progress. MDMA has long endured the reputation of a drug associated only with its abuse.

That is why Imperial College London neuropsychopharmacologist David Nutt said that “this is not a big scientific step.” According to Nutt, among many of his peers, “it’s been obvious for 40 years that these drugs are medicines.” Nevertheless, he acknowledges that it is a “huge step in acceptance.”

For the legions of people suffering from the psychological malady every day, that acceptance could make a lifetime of difference.

Follow Nate Church @Get2Church on Twitter for the latest news in gaming and technology, and snarky opinions on both.