Following years of lobbying and laboratory research on the medical uses of methylenedioxymethamphetamine, or MDMA, the U.S. Food and Drug Administration has decided to move forward with the drug.
Last week, the Multidisciplinary Association for Psychedelic Studies (MAPS) announced that the FDA has granted Breakthrough Therapy Designation to MDMA for the treatment of post-traumatic stress disorder (PTSD). Popularly known as a recreational drug, and as the main ingredient in ecstasy, MDMA has been shown to offer significant relief for sufferers of PTSD in clinical use trials conducted over the past several years, leading to the U.S. agency’s decision.
MAPS, which has been championing and fundraising for MDMA research for roughly 30 years, explained in a press release that the FDA’s granting of a Breakthrough Therapy Designation indicates the agency “has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for PTSD.” It also designates the agency’s intent to help develop and review the treatment faster than other candidate therapies.
According to MAPS, the non-profit organization has reached an agreement with the FDA under the Special Protocol Assessment Process for the design of two Phase 3 trials for MDMA-assisted psychotherapy for patients with severe PTSD in the near future.
“Reaching agreement with [the] FDA on the design of our Phase 3 program and having the ability to work closely with the agency has been a major priority for our team,” said Amy Emerson, Executive Director of the MAPS Public Benefit Corporation, in a release. “Our Phase 2 data was extremely promising with a large effect size, and we are ready to move forward quickly. With breakthrough designation, we can now move even more efficiently through the development process in collaboration with the FDA to complete Phase 3.”
The drug’s ability to help PTSD-sufferers cope with the lingering effects of trauma is attributed in large part to its capacity to produce feelings of euphoria, empathy, and heightened emotional and physical sensations–in other words, perhaps, giving sorely stressed brains the kind of neurochemical getaway that begets a little peace of mind. Those effects also seem to motivate recreational users, but unlike the self-dosed Saturday night version, official MDMA-assisted psychotherapy involves three administrations of the drug combined with established psychotherapeutic techniques.
Rick Doblin, Founder and Executive Director of MAPS, commented in a statement, “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 … Now that we have agreement with FDA, we are ready to start negotiations with the European Medicines Agency.”
In Phase 2 trials completed by MAPS, 61% of the 107 participants no longer qualified for PTSD two months after they underwent three sessions of MDMA-assisted psychotherapy, according to the group. After a year, that number grew to 68%, and among participants who had all suffered from chronic, treatment-resistant PTSD, on average for 17.8 years.
The randomized, placebo-controlled Phase 3 trials will assess the efficacy and safety of MDMA-assisted psychotherapy in a group of 200 to 300 participants with PTSD aged 18+ at sites in the U.S., Canada, and Israel. As Science reported, the trials could begin as soon as next spring and wrap up by 2021 if MAPS is able to find the estimated $25 million needed to conduct them.
As Science reflected, “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.”
David Nutt, a neuropsychopharmacologist at Imperial College London, told Science, “This is not a big scientific step … It’s been obvious for 40 years that these drugs are medicines. But it’s a huge step in acceptance.”