MAPS Statement on FDA’s Public Release of Complete Response Letter for MDMA-assisted Therapy

MAPS Statement on FDA’s Public Release of Complete Response Letter for MDMA-assisted Therapy

SAN JOSE, Calif., Sept. 04, 2025 (GLOBE NEWSWIRE) -- In August 2024, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Lykos Therapeutics, declining to approve MDMA-assisted therapy for Posttraumatic Stress Disorder (PTSD). Today, the…

MAPS Statement on FDA’s Public Release of Complete Response Letter for MDMA-assisted Therapy – Multidisciplinary Association for Psychedelic Studies – MAPS

San Jose, CA; September 4, 2025 — In August 2024, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Lykos Therapeutics, declining to approve MDMA-assisted therapy for Posttraumatic Stress Disorder (PTSD). Today, the FDA made this CRL publicly available for the first time, providing transparency into the agency’s decision-making process.  MDMA was erroneously criminalized in 1986 despite a recommendation from …

URGENT Episode: FDA Reveals Rejection Letter For MDMA Therapy Application

Today, the FDA shared the rejection letter for Lykos Therapeutics’ MDMA therapy application alongside several other controversial drug decisions. I’ve been tracking this issue for quite some time as I’ve been quite impressed with the efficacy and safety data on psychedelic therapy for treating mental health disorders such as treatment-resistant depressi…

BREAKING: FDA Publishes Lykos Therapeutics’ MDMA Complete Response Letter (CRL) - Psychedelic Alpha

FDA has published its complete response letter (CRL) to Lykos Therapeutics, citing durability, safety, and bias concerns in rejecting MDMA therapy for PTSD. Here, we very briefly unpack the letter.