MDMA-Assisted Therapy NDA Resubmitted to FDA for PTSD

The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) confirmed Resilient Pharmaceuticals, formerly MAPS Public Benefit Corporation and Lykos Therapeutics, has resubmitted its new drug application (NDA) for MDMA-assisted therapy for PTSD to the US Food & Drug Administration (FDA).¹

The resubmission follows the complete response letter (CRL) the FDA issued on August 9, 2024, recommending additional research on durability of response, safety characterization, and bias mitigation before reconsidering approval.² MAPS funded and initiated the clinical trial program underlying the application, completed in 2022, but has no active role in Resilient's current drug development program.¹

"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," said Rick Doblin, PhD, founder and president of MAPS.^{1 “}I'm grateful everyone who contributed to those trials, the donors, researchers, independent raters, and most importantly the participants, will see a new evaluation by the FDA.”

Doblin noted the data underlying the original application, including adverse events and clinical outcomes, were reported accurately despite partial functional unblinding among trial participants.

FDA Final Guidance on Psychedelic Drug Clinical Investigations

The FDA published final guidance titled Psychedelic Drugs: Considerations for Clinical Investigations in July 2026, finalizing a draft first issued in June 2023.³ The guidance addresses clinical trial design, safety characterization, therapist-delivered interventions, and long-term follow-up standards, the same areas identified in the 2024 CRL as needing further development. MAPS said the guidance reflects scientific approaches the organization discussed with the FDA over more than 20 years of engagement on psychedelic drug development.

“The drug evaluation and regulation system was not designed to evaluate drugs delivered as part of therapy, and it is worth getting right," said Betty Aldworth, co-executive director of MAPS.¹ “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.”

References

1. MAPS Responds to Report of Progress for MDMA-assisted therapy for PTSD with FDA. MAPS. Published August 10, 2026. Accessed August 10, 2026. https://maps.org/2026/08/10/maps-responds-to-report-of-progress-for-mdma-assisted-therapy-for-ptsd-with-fda/

2. Derman C. FDA Releases CRL Detailing Safety Concerns for MDMA-Assisted Therapy in PTSD. HCPLive. Published September 15, 2025. Accessed August 10, 2026. https://www.hcplive.com/view/fda-releases-crl-detailing-safety-concerns-mdma-assisted-therapy-ptsd

3. Psychedelic drugs: Considerations for Clinical Investigations. US Food and Drug Administration. Published July 2026. Accessed August 10, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/psychedelic-drugs-considerations-clinical-investigations