One Year After FDA’s MDMA Rejection: Insiders and Observers Reflect - Psychedelic Alpha

One Year After FDA’s MDMA Rejection: Insiders and Observers Reflect - Psychedelic Alpha

Last August, Lykos Therapeutics announced that the U.S. Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) to its new drug application (NDA) that sought to have MDMA-assisted therapy approved for PTSD. In real terms, the agency had rejected Lykos’ first shot at getting the drug approved. After a period of intense reporting last year, we shifted focus to what the future… Source

MAPS Urges Action: Open Letter to HHS Secretary and FDA Commissioner One Year After FDA Denial of MDMA-Assisted Therapy for PTSD – Multidisciplinary Association for Psychedelic Studies – MAPS

MAPS calls on HHS and FDA to prioritize science, compassion, and urgent regulatory reform to address PTSD affecting millions worldwide Despite successful Phase 3 trials, MDMA-assisted therapy remains out of reach — MAPS urges decisive federal leadership to save lives and help those suffering WASHINGTON, DC (August 14, 2025) — One year after the FDA’s denial of the New Drug Application for MDMA-assisted therapy for PTSD, the Multidisciplinary Ass…