Lykos Therapeutics, the company developing MDMA therapy for post-traumatic stress disorder (PTSD), recently faced setbacks when the Food and Drug Administration (FDA) rejected the treatment. Despite positive results from two Phase III clinical trials, the FDA had concerns about the design of the trials, missing data, biases, and allegations of unethical conduct, including a sexual assault of a trial participant by an unlicensed therapist. The rejection prompted the company to announce its plans to appeal the decision.
In a surprising turn of events, the scientific journal Psychopharmacology retracted three studies related to the MDMA therapy. These studies, which included data from Phase II clinical trials, were essential for the clinical development of the treatment. The retractions were based on protocol violations, unethical conduct at a clinical trial site, and undisclosed conflicts of interest by the authors. Despite the retractions, Lykos maintains that the articles are scientifically sound and contribute significantly to the study of potential PTSD treatments.
The retraction of the studies further complicates the situation for Lykos, as it now has to address the FDA’s request for an additional Phase III trial. While conducting another trial would be time-consuming, the company believes that many of the FDA’s concerns can be addressed with existing data, post-approval requirements, and references to scientific literature. However, the retracted studies were crucial for supporting the therapy with existing data and scientific literature, making Lykos’ appeal to the FDA more challenging.
Moving forward, Lykos will need to navigate the retraction of the studies, the FDA’s rejection of the treatment, and the appeal process. The company remains committed to developing MDMA therapy for PTSD and addressing the concerns raised by the FDA and scientific community. Despite the setbacks, Lykos is determined to continue its efforts to provide effective treatments for individuals suffering from PTSD and other mental health conditions.
