Expand / MDMA (credit: Getty | PYMCA/Avalon)
A recent academic publication has withdrawn three pivotal studies that supported the clinical progression of MDMA, commonly referred to as ecstasy, for treating post-traumatic stress disorder (PTSD). This development follows closely on the heels of the announcement that the Food and Drug Administration (FDA) denied approval for this treatment, notwithstanding favorable outcomes documented in two advanced Phase III clinical trials.
On Friday, Lykos Therapeutics, the firm behind this therapeutic approach, revealed it had received a formal denial from the FDA. The company indicated that this rejection echoed many concerns previously noted by both FDA officials and its expert advisory board. In June, this board voted decisively against endorsing the therapy. Key issues highlighted by the FDA included inadequacies in trial design, missing information, and potential biases stemming from individuals associated with these studies—including accusations of a cult-like enthusiasm surrounding psychedelic treatments. Notably, Lykos is an offshoot of MAPS (Multidisciplinary Association for Psychedelic Studies), an organization advocating for psychedelic research.
The concerns raised by FDA advisors are further compounded by disturbing reports regarding a participant’s alleged sexual assault during a Phase II trial perpetrated by an unlicensed therapist who was delivering MDMA-assisted psychotherapy.
For additional insights and information on related topics or updates on ongoing trials and regulatory shifts within therapeutic psychedelics, please stay tuned.
