A scientific journal has retracted three studies that supported the clinical development of MDMA (also known as ecstasy) as a psychedelic treatment for post-traumatic stress disorder. The move came just a day after it was reported that the Food and Drug Administration had rejected the treatment despite positive results from two phase III clinical trials.
On Friday, the company developing the therapy, Lykos Therapeutics, announced that it had received a denial letter from the FDA. Lykos said the letter reflected numerous concerns previously raised by the agency and its expert advisory panel, which voted overwhelmingly against approving the therapy in June. The FDA and its advisers identified flaws in the design of the clinical trials, missing data and various biases among people involved in the trials, including a perceived cult-like support for psychedelics. Lykos is a for-profit spinoff of the nonprofit psychedelic advocacy group the Multidisciplinary Association for Psychedelic Studies (MAPS).
FDA advisers also noted public allegations of sexual abuse of a trial participant during a Phase II trial by an unlicensed therapist providing MDMA-assisted psychotherapy.
In its statement Friday, Lykos said the FDA has asked the company to conduct an additional Phase III trial, which the company called a “very disappointing” request. Lykos said it would appeal the FDA's decision.
Withdrawals
“While conducting a new Phase III study would take several years, we continue to believe that many of the requests previously discussed with the FDA and made at the Advisory Committee meeting can be addressed with existing data, post-approval requirements or by reference to the scientific literature,” Lykos CEO Amy Emerson said in a statement.
On Saturday, Lykos’s ability to use existing data and scientific literature to support MDMA therapy became a little trickier. The journal Psychopharmacology issued retractions for three studies that reported phase II clinical data on the therapy. The studies included a 2019 rationale for a phase III trial design, a 2020 pooled analysis, and a 2020 study on how antidepressant use may affect response to MDMA therapy.
The retraction notice cited two reasons for the retractions, including “protocol violations amounting to unethical conduct” at one of the clinical trial sites — a reference to the sexual abuse allegations — and undisclosed conflicts of interest of the authors.
Regarding the sexual assault, the journal said that “the authors later confirmed that they were aware of these violations at the time of filing [the articles] but did not disclose this information to the journal or remove data generated by this site from their analysis.” Regarding the conflicts of interest, the journal alleges that the authors failed to fully disclose their affiliations with MAPS and its subsidiary, the MAPS Public Benefit Corporation, despite the fact that MAPS funded the studies.
Lykos disagrees with the decision to retract the papers, a statement to The New York Times said. “The papers remain scientifically sound and make important contributions to the study of potential treatments for PTSD,” the company said.
