Back to the drawing board for Lykos after failures on several grounds
Alcoholism & Drug Abuse Weekly August 16, 2024 DOI: 10.1002/adaw.34219 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | News report Peer reviewed |
|---|---|
| Key points | The FDA did not accept Lykos Therapeutics' application for MDMA as a PTSD treatment, instead requesting more information; the company says it will continue seeking approval, and three peer-reviewed studies were retracted the same day. |
Abstract
The Food and Drug Administration (FDA) did not accept the application of Lykos Therapeutics for MDMA as a treatment for post‐traumatic stress disorder (PTSD). In a letter dated Aug. 9 and released by Lykos Therapeutics, the for‐profit arm of the Multidisciplinary Association for Psychedelic Studies (MAPS), the company stated that it is disappointed in the FDA response, but that it intends to pursue the goal of approval. This announcement was followed by the retraction of three peer‐reviewed studies on Aug. 9 as well. The FDA did not completely reject the idea of ever approving MDMA, but asked Lykos for more information.