FDA publicly releases MDMA rejection letter; MAPS vows to press forward
Mental Health Weekly September 15, 2025 DOI: 10.1002/mhw.34582 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | News report Peer reviewed |
|---|---|
| Topics | MDMA |
| Key points | The FDA's Complete Response Letter to Lykos Therapeutics rejected approval of MDMA-assisted therapy for PTSD, citing concerns about treatment durability, study design, and prior MDMA use among participants. Critics contend these issues were not raised during earlier protocol discussions. |
Abstract
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.