Historic FDA approval granted for Ecstasy trial as PTSD treatment

The Multidisciplinary Association for Psychedelic Studies announced that the FDA has granted MDMA (aka Ecstasy/Molly) a "Breakthrough Therapy" designation as part of a treatment for posttraumatic stress disorder (PTSD). From the journal Science:

One of the main targets in the war on drugs could well become a drug to treat the scars of war. The U.S. Food and Drug Administration (FDA) has designated 3,4-methylenedioxymethamphetamine (MDMA), better known as the illegal drug ecstasy, a "breakthrough therapy" for posttraumatic stress disorder (PTSD), a status that may lead to faster approval.

The agency has also approved the design for two phase III studies of MDMA for PTSD that would be funded by the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit in Santa Cruz, California. MAPS announced the "breakthrough therapy" designation, made by FDA on 16 August, on its website today; if the group can find the money for the trials, which together could cost an estimated $25 million, they may start next spring and finish by 2021.

That an illegal dancefloor drug could become a promising pharmaceutical is another indication that the efforts of a dedicated group of researchers interested in the medicinal properties of mind-altering drugs is paying dividends. Stringent drug laws have stymied research on these compounds for decades. "This is not a big scientific step," says David Nutt, a neuropsychopharmacologist at Imperial College London. "It's been obvious for 40 years that these drugs are medicines. But it's a huge step in acceptance."