Our collective commitment to MDMA-assisted therapy remains unwavering
Dear friends,
I wanted you and all of our supporters to hear from us: today, Lykos Therapeutics announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for midomafetamine (MDMA) capsules used in combination with manualized therapy for PTSD. The CRL specifies the additional information Lykos will need to provide for the FDA to continue its evaluation. Read more in today’s announcements from Lykos.
When we began this journey four decades ago, and when you joined us as a supporter, we knew it wouldn’t be easy — and it hasn’t been. From struggling to raise funding to finding research partners to addressing criticism, MAPS has persevered through challenges both small and mighty.
We are evaluating MAPS’ path forward to support safe, legal access to the beneficial uses of MDMA and other psychedelics and to global regulatory approval of MDMA-assisted therapy. I remain confident that rigorous science, diligent research, and drug policy reform that catalyzes citizen advocacy will eventually win out on behalf of the millions of people who might benefit.
At MAPS, our journey continues with MDMA and beyond. MAPS is expanding its international therapist training and educational programs and is working with local experts to start a series of small pilot studies in MDMA-assisted individual and group therapy for PTSD in high-trauma/low-resource parts of the world. In the U.S. and in international forums, we’re hard at work advancing research, changing policy, and shaping culture, creating a post-prohibition world where people have legal and equitable access to psychedelics for healing, spirituality, religion, and personal growth.
We are living in a mental health crisis that has reached a critical level with more than 350 million people living with PTSD worldwide. Fortunately, a tool exists that can help address the suffering — psychedelic-assisted therapies.
We have made tremendous progress over 38 years in combatting drug war stigma, generating data showing the potential of psychedelic-assisted therapies to treat mental health conditions, and educating the public on how psychedelics can be safely integrated into society. Because of support from people like you, now, more than half of Americans support legal access to psychedelic-assisted therapies.1
While we are devastated to see the FDA’s response, today’s news shows us just how urgent our work is. There is still a need for more research to better understand the potential applications and risks associated with psychedelics. There is still a need for policy change at the state and federal levels to increase access. And there is still a need for education to help eliminate stigma and misunderstandings.
Your support of this vital work is more important than ever, so please make a gift today to help us advance research, change policy, and shape our culture so we can create a post-prohibition world where people have legal access to psychedelics for healing and personal growth.
We are grateful to remain on this journey with you, and look forward to meeting together with many of you next summer, June 16-20, in Denver at Psychedelic Science 2025!
To Seeing Past the Paradox,
Rick Doblin, PhD
MAPS Founder and President