FDA Panel Votes Against MDMA-Assisted Talk Therapy

On June 4, 2024, a panel of experts advising the Food and Drug Administration (FDA) on the use of the psychedelic midomafetamine (MDMA) for post-traumatic stress disorder (PTSD) voted 9-2 that MDMA in combination with talk therapy is not effective for treating PTSD, and 10-1 that the benefits of MDMA treatment do not outweigh its risks.[1] The panel had reviewed Lykos Therapeutics[2]’s new drug application and associated clinical research related to treating PTSD using MDMA, also known by its street name ecstasy, in combination with talk therapy.

The vote came after public comment and discussion, where several FDA staff and members of the advisory panel spoke about concerns such as gaps in the clinical research data, potential abuse of MDMA, and the lack of evidentiary support for the form of talk therapy used in clinical trial therapy sessions.

The discussion included patient testimonials of successful treatment, but also involved discussions of “functional unblinding” due to participants’ ability to tell whether they had received the experimental drug or the placebo, and serious allegations of misconduct by therapists during the trials.

While the panel’s vote is not binding on the FDA, based on the FDA’s past treatment of such panels, it is speculated that the FDA will likely follow the panel’s recommendation and not approve Lykos Therapeutics’s new drug application.

Following the panel’s vote, other psychedelic drugmakers such as Compass Pathways, Mind Medicine, and Atai Life Sciences have sought to distance themselves from Lykos’s clinical research and its controversy.[3]