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Back to the drawing board for Lykos' MDMA therapy

Alison Knopf

The Brown University Child & Adolescent Psychopharmacology Update September 12, 2024 DOI: 10.1002/cpu30905 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Peer reviewed
Intervention MDMA
Topics MDMA
Citations 1
Key points The FDA did not accept Lykos Therapeutics' application for MDMA as a PTSD treatment and requested more information.

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.

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