FDA publicly releases MDMA rejection letter; MAPS vows to press forward

In a historic move toward transparency, the U.S. Food and Drug Administration (FDA) on Sept. 4 publicly released its Complete Response Letter (CRL) rejecting the approval of midomafetamine (MDMA)‐assisted therapy for post‐traumatic stress disorder (PTSD). The letter, sent to Lykos Therapeutics in August 2024, outlines concerns about treatment durability, study design and prior MDMA use among participants — issues that critics say were not flagged during earlier protocol discussions.