FDA labels Ecstasy a “breakthrough therapy,” accelerates testing.

Science magazine celebrates the fast-tracking of studies on MDMA, the once-notorious rave drug that’s now on the verge of being approved to tread PTSD and other disorders:

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.”

Since 2012, FDA has designated close to 200 drugs as breakthrough therapies, a status that indicates there’s preliminary evidence that an intervention offers a substantial improvement over other options for a serious health condition. The agency aims to help develop and review these treatments faster than other candidate drugs.

A small U.S. study that first suggested MDMA could help treat PTSD was published in 2011. Since then, researchers in Canada, Israel, and the United States have jointly carried out larger phase II trials funded by MAPS; their results, which remain unpublished but have been reviewed by the FDA, were very good, says Doblin. Overall, 107 participants who had suffered from PTSD for an average of 17.8 years were treated in the phase II trials, [MAPS Executive Director Rick] Doblin says. Of the 90 patients who were available to be studied 12 months later, 61 no longer had PTSD.

In late July, says Doblin, MAPS and FDA agreed on how the coming phase III trials—usually the last hurdle before seeking a drug’s approval from regulators—should be conducted.

In past studies, patients in the control arm received a low dose of MDMA—a so-called “active placebo”—that made it harder for them to tell in which group they were. But that had a negative effect on the outcome of their psychotherapy, says Doblin, making MDMA look better by comparison. A low dose “activates people, but it does not provide the fear reduction that the full doses would and so they are more uncomfortable, more unhappy,” Doblin says.

That’s why FDA decided it would be better to test MDMA-assisted psychotherapy against psychotherapy with an inactive placebo. But the agency and MAPS agreed on additional measures to ensure that the doctors who evaluate the patients don’t know if they received the real drug.

Note: they’re attempting to crowdfund the next phase of research, so if you’d like to help the science go forward, here’s the place to do it.

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