Health & Medicine Law Legalization News Psychedelics U.S.

MDMA on cusp of FDA approval

 

The Multidisciplinary Association of Psychedelic Studies (MAPS) has worked for the last 35 years to shift the perception around psychedelics as a treatment tool for mental health issues. Now, with the release of data from its Phase III trial with the FDA for the use of MDMA (ecstasy) to treat PTSD, MAPS’ work has coalesced into findings that could change the mental health treatment landscape as we know it.

MDMA is on the cusp of FDA approval to treat PTSD — not just for military veterans, but for an array of people who have suffered from abuse and other trauma-inducing events.

In 2017, the FDA granted MDMA “breakthrough therapy status” in anticipation of approving it as a medication for mental health, and the release of MAPS’ latest statistically significant findings constitutes a huge leap towards legalization.

Legal MDMA-Assisted Therapy Is Likely Within Next Couple YearsPhoto by Pornpak Khunatorn/Getty Images

The conversation around the legalization of psychedelic drugs is not new to the mental health community. Trials testing the efficacy of psychedelics such as LSD for mental illness began as early as the 1950s. By the 1960s more than 1,000 papers had been published about LSD as a treatment for depression, alcoholism, schizophrenia, and as an adjunct to psychotherapy. These trials lacked the scientific rigor necessary for legitimacy in the eyes of the FDA, but due in no small part to the work of MAPS, legitimacy is no longer the stumbling block it once was.

MDMA showed efficacy for treating PTSD in six MAPS Phase II trials, providing a cost-saving and clinically beneficial treatment for those with severe or extreme chronic PTSD resulting from any cause. The Phase III trial is the first of any psychedelic-assisted therapy. It was a randomized, blinded study designed under an FDA-approved Special Protocol Assessment. 90 patients with severe, chronic PTSD were enrolled in the trial and randomized to receive either MDMA or a placebo. The results, according to the lead author of the paper, Jennifer Mitchell, Ph.D., were significant. “People with the most difficult-to-treat diagnosis, often considered intractable, respond just as well to this novel treatment as other participants. In fact, participants diagnosed with the dissociative type of PTSD experienced a greater reduction in symptoms than those without the dissociative subtype.”

To Read The Rest Of This Article By Julie Aitcheson on The Fresh Toast

Published: May 15, 2021

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