A non-binding but influential committee expressed disapproval of a drug application that would have permitted the use of MDMA or ecstasy for the clinical treatment of PTSD.
The Food and Drug Administration advisory panel voted on June 4 2024 against the claim that therapy which included the use of 3,4-methylenedioxymethamphetamine (better known as MDMA or commonly known as ecstasy) was effective in treating patients with post-traumatic stress disorder or PTSD.
The vote wasn’t close: 9 of the panel’s 11 voting members cast ballots against supporting the effectiveness of MDMA-assisted therapy.
Advisory panels’ decisions do not have force of law but the FDA usually follows their advice, according to Axios.
The decision involved a drug application from Lykos Therapeutics and followed the release of an FDA briefing document which suggested serious problems with the studies backing the effectiveness of ecstasy-assisted therapy for PTSD and referred to them as “challenging to interpret.”
While the briefing document acknowledged that participants in the studies cited “appear to experience rapid, clinically meaningful, durable improvement in their PTSD symptoms” after MDMA-assisted therapy, the data is considered “challenging to interpret.”
Part of the reason, the document said, is the effect of rolling on ecstasy is so profound and obvious that double-blind studies with the use of real MDMA and placebos are almost useless. In double-blind studies, both the patient and the therapist are officially unaware of whether a dose is real or placebo. But apparently 90% of the participants who were given ecstasy were able to guess they’d been given the real drug and not a placebo; 75% of the other recipients correctly guessed they’d gotten the placebo. Staff monitoring patients were likewise able to guess which patients were rolling and which received a sugar pill based on behavior.
The briefing document also found that many participants dropped out of the study — approximately 25% between the initial dose and a follow-up exam six to eighteen months later. Panel members have told media after the vote that they also shared concerns expressed in the document about “limited clinical laboratory data” on health effects, particularly in regard to cardiac safety and liver function.
The Veterans’ Administration National Center for PTSD estimates that approximately 5% of US population is suffering from PTSD in any given year.
Image by Christian Trick from Pixabay
