Denver, Colorado, USA — August 10, 2026
Multidisciplinary Association for Psychedelic Studies (MAPS) responded to reports that Resilient Pharmaceuticals, formerly known as MAPS Public Benefit Corporation and Lykos Therapeutics, has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking potential approval of MDMA-assisted therapy for post-traumatic stress disorder (PTSD). The reported resubmission follows the FDA’s Complete Response Letter issued in August 2024, which requested additional research and information concerning durability of treatment response, safety characterization and measures to reduce potential bias in the clinical evidence. MAPS said it initiated and funded the clinical research program supporting the original application but does not have an active role in Resilient Pharmaceuticals’ current drug development program. The reported NDA resubmission represents a new opportunity for the FDA to evaluate the available clinical evidence and determine whether the investigational treatment meets regulatory standards for safety and efficacy.
FDA Guidance Addresses Psychedelic Clinical Development
MAPS highlighted the FDA’s publication in July 2026 of its final guidance, “Psychedelic Drugs: Considerations for Clinical Investigations,” which addresses important considerations for developing psychedelic therapies. The guidance covers areas including clinical trial design, safety characterization, therapist-delivered interventions and long-term follow-up. MAPS said these areas overlap with scientific and regulatory questions the organization has discussed with the FDA over many years of research into psychedelic-assisted therapy. The organization emphasized that MDMA-assisted therapy involves more than administration of an investigational drug, with the proposed therapeutic model incorporating trained therapist teams, patient preparation, therapeutic support and integration, and rigorous safety procedures. According to MAPS, establishing appropriate frameworks for evaluating treatments delivered in combination with psychotherapy is important because conventional drug-development approaches may not fully capture the interaction between pharmacological effects and structured therapeutic interventions.
MDMA-Assisted Therapy Program Built Through Long-Term Research
The MDMA-assisted therapy program for PTSD originated from research initiated and funded by MAPS, with clinical development extending from the 1990s through 2022. The organization supported preclinical toxicity studies, a Phase 1 dose-response safety study, five Phase 2 studies and two Phase 3 studies that formed the foundation of the regulatory application. The initial FDA application was ultimately rejected in 2024 through a Complete Response Letter, which raised questions that included durability of response, safety and potential bias. MAPS said the reported resubmission does not include a new Phase 3 study and will instead undergo a new regulatory evaluation based on the available evidence and additional information. The organization continues to advocate for rigorous evaluation of psychedelic-assisted treatments while emphasizing the importance of therapist training, patient safety and appropriate clinical implementation. The regulatory outcome remains uncertain, and FDA review of the resubmitted application will determine whether the available evidence supports potential approval of MDMA-assisted therapy for PTSD.
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MAPS Continues Focus on Psychedelic Therapy Standards
Beyond the specific MDMA-assisted therapy application, MAPS continues to work on frameworks intended to support safe and responsible integration of psychedelic care. The organization operates initiatives focused on therapist education, policy development and psychedelic research, while also addressing questions around equitable access and patient safety. MAPS said its long-term objective is to establish evidence-based approaches for therapist training, clinical safety and treatment delivery that can be applied as psychedelic-assisted therapies progress through regulatory evaluation. The organization also plans to convene researchers, clinicians and other stakeholders through future psychedelic science initiatives. The reported NDA resubmission marks another important stage in the regulatory history of MDMA-assisted therapy for PTSD, while the FDA’s updated psychedelic-drug guidance provides a more defined framework for evaluating complex treatments that combine an investigational medicine with structured therapeutic intervention..
Source:MAPS,press release
