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

Key Points

FDA's Complete Response Letter rejected MDMA therapy for PTSD, highlighting treatment durability concerns.
The letter raised issues regarding study design and participant history, indicating prior MDMA use might have influenced results.
Critics noted that these concerns were not previously addressed in protocol discussions, raising transparency issues.
MAPS aims to continue pushing for MDMA therapy approval despite the FDA's rejection, emphasizing potential therapy benefits.

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.

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Cite This Study

Valerie A. Canady (Fri,) studied this question.

synapsesocial.com/papers/68dc1e3b8a7d58c25ebb1a37 https://doi.org/https://doi.org/10.1002/mhw.34582