- The reported resubmission of the New Drug Application will initiate a new evaluation of the treatment’s safety and efficacy for potential FDA approval
- Recently updated FDA guidance, Psychedelic Drugs: Considerations for Clinical Investigations, reflects scientific approaches MAPS has discussed with the agency over more than 20 years
- The therapeutic model, including trained therapist teams, preparation and integration, and rigorous safety protocols, remains central to how MDMA-assisted therapy can best serve patients
August 10, 2026 — The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) today responded to an August 9 report by Psychedelic Alpha indicating that Resilient Pharmaceuticals (formerly MAPS PBC and Lykos Therapeutics) has resubmitted its new drug application (NDA) for MDMA-assisted therapy for PTSD to the U.S. Food and Drug Administration (FDA). The resubmission follows the Complete Response Letter issued on August 9, 2024, which recommended additional research related to durability of response, safety characterization, and steps to minimize potential for bias.
MAPS initiated and funded the clinical research on MDMA-assisted therapy, completed in 2022, that the application builds on. Although MAPS incubated the public-benefit pharmaceutical company, it has no active role in Resilient’s drug development program.
Two years after FDA rejected the initial application for MDMA-assisted therapy for PTSD, Resilient’s new NDA is being submitted without a new Phase 3 study. We knew the FDA wasn’t saying no, just not yet. We believed the data were valid and that adverse events and clinical outcomes were reported accurately, though positive adverse events had not been gathered at that time. Despite partial functional unblinding, the therapists provided high-quality care in treating the placebo subjects as well as the subjects who received MDMA. I’m grateful that everyone who contributed to those trials — the donors, researchers, independent raters, and most importantly the participants — will see a new evaluation by the FDA.
— Rick Doblin, Ph.D., Founder and President, MAPS
In July 2026, the FDA published its final guidance, Psychedelic Drugs: Considerations for Clinical Investigations. This guidance finalizes a draft first issued in June 2023 and addresses clinical trial design, safety characterization, therapist-delivered interventions, and long-term follow-up standards — areas at the center of the CRL’s recommendations.
The new guidance reflects the approaches MAPS developed with the FDA after decades of scientific collaboration. The drug evaluation and regulation system was not designed to evaluate drugs delivered as part of therapy, and it is worth getting right. The clarity this guidance provides was earned by the researchers, therapists, and participants who believe this treatment deserves a rigorous evaluation of its scientific merit. We applaud the FDA for recognizing both the promise and the complexity of novel treatments for life-threatening mental health conditions.
— Betty Aldworth, Co-Executive Director, MAPS
MAPS was founded in 1986 in response to the 1985 criminalization of MDMA and initiated a strategy to draw a roadmap with the FDA to evaluate psychedelic-assisted therapies through pre-clinical animal toxicity studies, a Phase 1 dose-response safety study, five completed Phase 2 studies, and two Phase 3 studies. With philanthropic donations, MAPS funded the clinical research program on MDMA-assisted therapy for PTSD from the early 1990s through 2022.
Regardless of the outcome of any individual application, the questions now facing the field are the ones MAPS was built to answer: how therapists are trained, how patient safety and outcomes are maximized, and whether the people most affected by trauma can access the treatments research has made possible.
— Ismail Ali, J.D., Co-Executive Director, MAPS
MAPS continues to advance frameworks for safe and responsible integration of psychedelic care through its Therapist Education Program, building equitable policy frameworks through initiatives like its Psychedelics for System-Impacted People (PSIP) project, and convening the field at Psychedelic Science 2027 (PS27) in Denver.
For more information about MAPS, visit MAPS.org.
ABOUT MAPS
Founded in 1986, MAPS is a 501(c)(3) nonprofit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful use of psychedelics and marijuana. MAPS previously sponsored the most advanced psychedelic-assisted therapy research in the world and continues to support psychedelic and marijuana research with a focus on the people and places most impacted by trauma. MAPS incubated Resilient Pharmaceuticals (formerly Lykos Therapeutics and the MAPS Public Benefit Corporation), and The Zendo Project, a leader in psychedelic harm reduction. Since MAPS was founded, philanthropic donors and grantors have given more than $150 million to advance psychedelic research, change drug policy, and shape culture.