Rick Doblin, PhD, Weighs in on the FDA CRL for MDMA-Assisted Therapy

Rick Doblin, PhD, founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), discussed the recent release of the US Food and Drug Administration (FDA) Complete Response Letter (CRL) to Lykos Pharmaceuticals’ (now Resilient) application for MDMA-assisted therapy in posttraumatic stress disorder (PTSD).¹ Doblin welcomed the FDA’s decision to publish the CRL, emphasizing that transparency is critical for advancing the field.² Contrary to comments that the FDA opposes psychotherapy, Doblin pointed out that the agency expressed discomfort with the therapeutic model used and requested further evidence that MDMA be paired with an evidence-based therapy. He stressed that the CRL reflects a “not yet” rather than a rejection of MDMA-assisted therapy.

Key FDA concerns included adverse event reporting, third-party data validation, and review of therapy session recordings. Doblin argued these issues are addressable and believes proactive disclosure will facilitate regulatory progress. He underscored that MDMA functions synergistically with therapy, reducing amygdala hyperactivity, enhancing prefrontal and hippocampal connectivity, and releasing oxytocin to strengthen therapeutic alliance. This neurobiological profile supports trauma processing and sustained symptom improvement.

Doblin also highlighted international developments, including recent compassionate access programs in Australia. He remains optimistic about US regulatory advances in the next year, citing bipartisan interest and Department of Defense–funded trials in active-duty service members. For psychiatrists, he emphasized that MDMA is not a standalone treatment but a catalyst for therapy, potentially revitalizing clinical practice beyond pharmacologic management and opening pathways for integrative, personalized psychedelic-assisted approaches.

The MAPS team is happy to answer any further questions; feel free to reach out to education@maps.org.

Dr Doblin is the founder and president of MAPS. He received his doctorate in Public Policy from Harvard’s Kennedy School of Government, where he wrote his dissertation on the regulation of the medical uses of psychedelics and marijuana and his Master’s thesis on a survey of oncologists about smoked marijuana vs the oral THC pill in nausea control for cancer patients.

References

1. Complete Response, NDA 215455. US Food and Drug Administration. August 8, 2024. Accessed September 24, 2025. https://psychedelicalpha.com/wp-content/uploads/2025/09/CRL_NDA215455_20240808.pdf

2. MAPS statement on FDA’s public release of Complete Response Letter for MDMA-assisted therapy. Press release. September 4, 2025. Accessed September 24, 2025. https://www.morningstar.com/news/globe-newswire/9523929/maps-statement-on-fdas-public-release-of-complete-response-letter-for-mdma-assisted-therapy