Dear Friends and Allies,
On June 4, 2024, the U.S. Food and Drug Administration (FDA) convened a meeting of the Psychopharmacologic Drugs Advisory Committee to evaluate Lykos Therapeutics’ (Lykos) New Drug Application (NDA) for MDMA-assisted therapy for PTSD. First and foremost, we applaud both the FDA and Lykos, MAPS’ former subsidiary, for their diligent efforts in preparation and presentation at the meeting.
FDA’s review of this first New Drug Application for a psychedelic-assisted therapy is ongoing, and their decision will encompass a holistic review of the application and its safety data. Several novel elements merit careful consideration, and we appreciate the process that is being undertaken.
Since 2014, Lykos Therapeutics has built upon the foundation laid by MAPS beginning in 1986, working closely with the FDA to design and implement clinical trials for MDMA-assisted therapy for PTSD. While challenges remain, the forward-thinking approach and collaboration among all stakeholders inspire hope for the future of psychedelic-assisted therapies.
We are grateful to the Lykos team, which has full, independent responsibility for the NDA and commercial activities if approved, for their dedication to navigating the New Drug Application through the FDA regulatory process. We also extend our deepest thanks to the participants, researchers, and donors whose contributions have been instrumental in advancing MDMA-assisted therapy for PTSD. The bravery of all the participants who shared their personal experiences provides invaluable insights for the continued evolution of psychedelic research.
While we wanted to take a moment to speak to the current environment, MAPS’ mission extends beyond it. We continue to support research and policies for psychedelic-assisted therapies because integration into existing healthcare structures promotes safety, accountability, and accessibility. Yet we envision a future where psychedelic-assisted therapies are a key tool available for mental health and wellness worldwide. We also recognize that such a future relies on a greater shared understanding of psychedelics and their potential benefits and risks, policy systems that support the dignity and rights of people who use psychedelics and other drugs, and innovative multidisciplinary research to ensure accessibility and culturally appropriate integration.
Thank you for your support through the decades of challenges we have overcome as we create a post-prohibition world together.
Your friends at MAPS