FDA’s Rejection of Lykos’ MDMA-Assisted Therapy for PTSD: A Setback but Not a Roadblock for Psychedelic Research

FDA Rejection:
The FDA rejected Lykos Therapeutics' application for MDMA-assisted therapy for post-traumatic stress disorder (PTSD) due to insufficient evidence of its benefits to justify the associated risks.

Retraction of Studies:
Three studies related to the use of MDMA for PTSD treatment were retracted by the journal Psychopharmacology due to "protocol violations amounting to unethical conduct" at one of the study sites.

Ethical Concerns:
The retraction highlighted ethical violations, including the failure to disclose potential competing interests and the manipulation of trial results.

Impact on Psychedelic Research:
Despite the setback, experts believe that the rejection will not halt the progress of psychedelic therapies. It is seen as a delay that underscores the need for rigorous and ethical research.

Future Directions:
Lykos plans to request a meeting with the FDA to discuss the agency's recommendations for a resubmission and to seek guidance for an additional Phase III trial.

Broad Implications:
The decision reflects the FDA's cautious approach to approving new therapies, emphasizing the importance of high-quality data and ethical conduct in clinical trials.