MAPS Statement on FDA’s Public Release of Complete Response Letter for MDMA-assisted Therapy

SAN JOSE, Calif., Sept. 04, 2025 (GLOBE NEWSWIRE) -- In August 2024, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Lykos Therapeutics, declining to approve MDMA-assisted therapy for Posttraumatic Stress Disorder (PTSD). Today, the FDA made this CRL publicly available for the first time, providing transparency into the agency’s decision-making process.

MDMA was erroneously criminalized in 1986 despite a recommendation from a federal administrative law judge that MDMA be placed in Schedule III. The rejection prolongs four decades of unnecessary suffering and delays a potentially life-saving treatment for the 13 million Americans living with PTSD. MAPS remains committed to expanding access to psychedelic therapies for those who cannot wait. Below is a statement from Rick Doblin, MAPS Founder & President:

We commend the FDA, Commissioner Makary, and HHS Secretary Kennedy for making the Complete Response Letter public so the entire field can understand FDA’s reasoning. But let’s be clear: the CRL reveals a devastating truth — the FDA moved the goalposts. In 2017, FDA selected the Phase 3 protocol design after a formal Special Protocol Assessment process, then, after the trials were complete and the application accepted, FDA shifted its standards regarding the approach to the challenge of conducting double-blind studies. In addition, FDA demanded more information after patients and researchers had already poured years of their lives into this process.

The cost of this bureaucratic backpedaling is not abstract. Thirteen million Americans live with PTSD today. Every year of delay means more will die by suicide and more remain trapped in cycles of trauma and despair. They deserve better.

The science is clear, the urgency is undeniable, and the human suffering is immense. Lykos will continue negotiations with the FDA. MAPS will keep driving forward: incubating and accelerating new MDMA-focused research, training therapists around the globe, catalyzing humanitarian projects in high trauma/low resource areas of the world, and building the infrastructure for a future where psychedelic-assisted healing and personal growth is not delayed by shifting politics, but delivered as a matter of compassion and justice.

This is bigger than one agency’s decision. This is about the future of mental health, the integrity of science, and the moral responsibility we all share. We will not stop until safe, legal access to psychedelic-assisted therapies and psychedelics for personal growth are a reality for everyone who needs it.
Rick Doblin, MAPS Founder & President

MAPS will host a media briefing tomorrow September 5 at 10:30 AM ET to discuss the FDA’s publication of the CRL. The briefing will feature MAPS leadership providing analysis of the FDA’s decision, MAPS’ continued research initiatives, and implications for the psychedelic field. Registration for the media briefing can be found here.

Media Contact:
media@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 uses 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 Lykos Therapeutics, a drug-development public benefit company, and The Zendo Project, a leader in psychedelic harm reduction. Since MAPS was founded, philanthropic donors and grantors have given more than $140 million to advance psychedelic research, change drug policy, and shape culture.

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