You Won't Believe Who Called MDMA a Breakthrough Medicine

By David Jenison on October 25, 2018

The Food & Drug Administration (FDA) did, that's who! 

The same government bureaucrats who blinked at rescheduling cannabis in 2016 officially designated MDMA a "breakthrough" treatment for post-traumatic stress disorder (PTSD). What. The. Fuck. We're not complaining, but we expected the FDA to recognize the therapeutic properties of cannabis before applying the "medical" tag to ecstasy, vitamin E, molly, disco biscuits or whatever name you prefer to call methylenedioxymethamphetamine (MDMA). 

The shocking move took place in August 2017 when the Multidisciplinary Association for Psychedelic Studies (MAPS) informed the public that the FDA granted breakthrough therapy designation for MDMA-assisted PTSD treatment. A protocol agreement is also in place for Phase 3 trials, which is traditionally the final testing stage before a medication is made available to doctors. Between 200 and 300 adults will participate in a pair of trials taking place in the U.S., Canada and Israel, and the participants will engage in 12 weeks of psychotherapy paired with three day-long sessions of either MDMA or a placebo. If the trials succeed as expected, medical molly will literally be a thing. 

Per the MAPS press release, "By granting Breakthrough Therapy Designation, the FDA has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for 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," added MAPS founder and executive director Rick Doblin, who has advocated for MDMA research for decades. "Now that we have agreement with the FDA, we are ready to start negotiations with the European Medicines Agency."

Doblin co-authored one of the first studies on MDMA and PTSD in 2011. At the time, the researchers concluded, "MDMA-assisted psychotherapy can be administered to post-traumatic stress disorder patients without evidence of harm, and it may be useful in patients refractory to other treatments." More clinical studies followed. 

One hundred and seven adults participated in the Phase 2 trials, and 61 percent of the individuals who combined MDMA and psychotherapy no longer meet the diagnostic criteria for PTSD two months after treatment. At the one year mark, that percentage increased to 68 percent. To put these recoveries in context, the participants all suffered from chronic, treatment-resistant PTSD for an average of 18 years. 

How serious is the FDA about this? The answer lies in the breakthrough therapy designation, which the FDA describes as a fast-track classification "intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy."

Science reported the breakthrough designation this way: "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. It's been obvious for 40 years that these drugs are medicines," London-based neuropsychopharmacologist David Nutt told Science. "But it's a huge step in acceptance."

Or as the Caring for the Ages journal put it in October 2017, "Psychedelics and other hallucinogenic drugs, including THC, are largely unavailable today, but that may change in the future. They clearly have shown great promise for some conditions that cause extreme suffering."

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