A scientific journal has retracted three studies underpinning the clinical development of MDMA—aka ecstasy—as a psychedelic treatment for post-traumatic stress disorder. The move came just a day after news broke that the Food and Drug Administration rejected the treatment, despite positive results reported from two Phase III clinical trials.
On Friday, the company developing the therapy, Lykos Therapeutics, announced that it had received a rejection letter from the FDA. Lykos said the letter echoed the numerous concerns raised previously by the agency and its expert advisory committee, which, in June, voted overwhelmingly against approving the therapy. The FDA and its advisers identified flaws in the design of the clinical trials, missing data, and a variety of biases in people involved with the trials, including an alleged cult-like support of psychedelics. Lykos is a commercial spinoff of the psychedelic advocacy nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS).
FDA advisers also noted the public allegations of a sexual assault of a trial participant during a Phase II trial by an unlicensed therapist providing the MDMA-assisted psychotherapy.
In its statement on Friday, Lykos said that the FDA has requested that the company run an additional Phase III trial, which the company called a “deeply disappointing” request. Lykos said it would appeal the FDA’s decision.
Retractions
“While conducting another Phase III study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the Advisory Committee meeting can be addressed with existing data, post-approval requirements, or through reference to the scientific literature,” Lykos CEO Amy Emerson said in a statement.
On Saturday, using the existing data and scientific literature to support MDMA therapy got a little more difficult for Lykos. The journal Psychopharmacology posted retraction notices for three studies that involved Phase II clinical data of 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 the 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 assault allegations—and undisclosed conflicts of interest by the authors.
With regard to the sexual assault, the journal said that “the authors have subsequently confirmed that they were aware of these violations at the time of submission of [the articles] but did not disclose this information to the journal or remove data generated by this site from their analysis.” For the conflicts of interest, the journal claims the authors did not 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 articles, according to a statement to The New York Times. “The articles remain scientifically sound and present important contributions to the study of potential treatments for PTSD,” the company said.
Source link
