Wrapping up nearly 38 years of rigorous research, a leading psychedelic research nonprofit is inching closer to proposing a new pharmaceutical drug: 3,4-methylenedioxymethamphetamine (MDMA) for post-traumatic stress disorder (PTSD).
MAPS Public Benefit Corporation (MAPS PBC) announced Wednesday that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for MDMA-assisted therapy. The application included data from two randomized, double-blind Phase 3 studies on MDMA, MAPP1 and MAPP2, as well as numerous earlier trials.
The nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) created MAPS PBC in 2014 with the goal to advance its research and drug development program for investigational MDMA-assisted therapy.
“As cannabis, MDMA, psilocybin, and other drugs inch closer to potential FDA approval as safe and effective treatments, yet another harm of the War on Drugs is revealed: decades of missed opportunity to reduce suffering among people living with debilitating conditions,” MAPS Director of Communications Betty Aldworth tells Forbes in an email.
The approval is long overdue, she says.
“Four decades after the DEA yanked MDMA out of therapists’ hands, through the groundbreaking and ceaseless work of MAPS and the people who believed in us, we may be on the precipice of MDMA becoming a medicine again,” Aldworth says. “Our work is far from done, as there are many more harms of prohibition to correct through policies and research rooted in science and compassion.”
According to the U.S. Department of Veterans Affairs, National Center for PTSD, over 13 million Americans live with PTSD during any given year, with over 350 million worldwide. And researchers at MAPS believe MDMA can provide unique psychopharmacological benefits such as decreased feelings of fear and defensiveness, increased feelings of wellbeing, increased sociability, and extroversion as well as other effects, after decades of investigation.
The FDA Approval is Worth the Wait
“When I started MAPS in 1986, the FDA was still blocking all research with psychedelics,” MAPS’ Founder and President Rick Doblin, Ph.D. said in the announcement. “MAPS had to try, though we might never succeed, to gather sufficient data about the safety and efficacy of MDMA-assisted therapy to seek approval for prescription use. As it has turned out, it took 37 ½ years to gather the necessary data to seek approval! All the effort and time have been totally worth it for the progress that we have seen in our research and the millions of people we hope to help through the public-benefit pharmaceutical model if FDA does approve the treatment.
“By breaking that barrier, we have opened doors for others to conduct their own promising research into psychedelic-assisted therapies with psilocybin, ayahuasca, ketamine, and more. The novel approaches undertaken in psychedelic-assisted therapy research have led to fundamental shifts in our understanding of how these devastating mental health conditions can.”
The Phase 3 clinical trials and NDA submission were funded in part through multiple fundraising campaigns, most notably a challenge grant from Tim Ferriss and the Saisei Foundation, as well as grants from the Steven & Alexandra Cohen Foundation. Thousands of other supporters contributed as well.
MAPS recently completed MAPP2, the second of two Phase 3 trials to support FDA approval of this breakthrough therapy.
In the first Phase 3 study, 88% of participants with severe PTSD experienced a clinically significant reduction in PTSD diagnostic scores two months after their third session of MDMA-assisted therapy, compared to 60% of those who took a placebo. Furthermore, 67% of participants in the MDMA group compared to 32% of participants in the placebo group no longer met the criteria for PTSD two months after the sessions.
The FDA submission represents a significant milestone in MAPS researchers’ march towards federal approvals.