A day after the regulator denied approval of Lykos’ MDMA-assisted PTSD therapy, a medical journal pulled three studies related to the use of the psychedelic in the indication.
The medical journal Psychopharmacology on Saturday retracted three papers related to the use of the psychiatric substance MDMA for the treatment of post-traumatic stress disorder.
The decision to pull the studies was driven by “protocol violations amounting to unethical conduct” at one of the study sites, according to the journal’s retraction note. The authors of the studies also confirmed to Psychopharmacology that they knew of these breaches when they submitted their manuscript “but did not disclose this information to the journal or remove data generated by this site from their analysis.”
Many of the authors failed to fully disclose a “potential competing interest,” according to the retraction notice, while some of the researchers were affiliated with either the Multidisciplinary Association for Psychedelic Studies or one of its subsidiaries, which funded and provided the MDMA used in the studies.
Allison Feduccia, an author in all three studies, agreed with the retraction but disputes the language that Psychopharmacology used in the retraction note. In an interview with STAT News, Feduccia said that she only agreed to the retraction because the journal would not allow them to amend the studies’ data.
Other researchers on the studies—including Michael Mithoefer, Lisa Jerome, Berra Yazar-Klosinski and Rick Doblin—registered their disagreement with the retraction. The remaining authors did not return Psychopharmacology’s request for comment.
Saturday’s retraction comes just a day after the FDA rejected Lykos Therapeutics’ investigational MDMA-assisted regimen for post-traumatic stress disorder (PTSD). In its Complete Response Letter, the regulator said that Lykos’ application “could not be approved based on data submitted to date” and called for an additional Phase III trial.
Lykos is planning to request a meeting with the FDA to “ask reconsideration of the decision” and to seek guidance for its resubmission.
The FDA’s rejection is in line with the verdict of its Psychopharmacologic Drugs Advisory Committee, which in June 2024 voted 10–1 against Lykos. During the panel discussion, the external experts raised concerns about selection bias and the functional unblinding of Lykos’ Phase III study to support its MDMA therapy.
The panelists also flagged the “potential for some misconduct and manipulating the trial results,” according to consumer representative Kim Witczak, who voted against Lykos.
In May 2024, the Institute for Clinical and Economic Review (ICER) released a scathing report on Lykos’ MDMA-assisted therapy, questioning the enrollment of patients who had been “pulled heavily” from a community with deep interest in the use of psychedelics. Some therapists and patients also had “very strong prior beliefs” about MDMA.
In addition, the ICER report revealed that there had been “pressures” to make the study’s results “favorable.”
