Back to the drawing board for Lykos' MDMA therapy
The Brown University Child & Adolescent Psychopharmacology Update September 12, 2024 Peer reviewed DOI: 10.1002/cpu30905 via OpenAlex
Summary
The FDA did not accept Lykos Therapeutics' application for MDMA as a treatment for PTSD, expressing the need for more information rather than a complete rejection of the drug's approval. Lykos expressed disappointment but plans to continue pursuing approval. Additionally, three peer-reviewed studies were retracted on the same day.
Study at a glance
| Key finding | The FDA requested more information from Lykos Therapeutics regarding their application for MDMA as a PTSD treatment instead of outright rejecting it. |
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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.