FDA was Right to Decline Approval for MDMA-Assisted Therapy for PTSD and Encourage Further Research

August 9, 2024

FDA was Right to Decline Approval for MDMA-Assisted Therapy for PTSD and Encourage Further Research

WASHINGTON, D.C. - The Food and Drug Administration (FDA) on Friday declined to approve midomafetamine (MDMA)-assisted therapy as a treatment for posttraumatic stress disorder (PTSD). Treatment with the psychedelic was to be administered along with psychotherapy.

In testimony in June 2024 before a FDA advisory committee, Public Citizen urged the agency not to approve MDMA because of concerns about its safety and effectiveness and the conduct of the main clinical trial. After a full discussion of the available evidence, the advisory committee voted overwhelmingly against the use of MDMA for treating PTSD. Dr. Robert Steinbrook, director of Public Citizen's Health Research Group, released the following statement:

"The FDA made the right decision by declining to approve MDMA based on the data submitted to date and by requesting that Lykos Therapeutics conduct an additional Phase 3 trial to further study the safety and effectiveness of the drug. Although psychedelic drugs are a promising approach to mental health care, FDA approval of a new drug should always be based on rigorous evidence of safety and effectiveness. By declining to approve MDMA, the FDA will encourage the company as well as other researchers studying psychedelic drugs to conduct better clinical trials."