FDA Advisory Panel Finds MDMA Ineffective for PTSD Treatment, Could Jeopardize Approval – Major Setback for Lykos Therapeutics

Washington, D.C. – A panel of experts advising the Food and Drug Administration raised concerns regarding the effectiveness of using the psychedelic MDMA for post-traumatic stress disorder. The panel’s findings indicate that the available evidence does not conclusively demonstrate the drug’s efficacy or the balance between its benefits and risks.

The FDA advisory panel’s vote, with a margin of 9-2 against the effectiveness of MDMA in conjunction with talk therapy for PTSD, presents a significant setback for proponents of the drug and Lykos Therapeutics, the sponsor of clinical trials. Concerns about the drug’s potential approval for mainstream mental health care were heightened by a 10-1 vote indicating that the benefits of MDMA treatment might not outweigh its risks.

While the FDA may consider the panel’s advice, the agency is not bound to follow the recommendation. However, feedback during the meeting revealed major obstacles in the clinical research process that may impede the drug’s approval. Uncertainties in the data, concerns about abuse potential, and insufficient evidence supporting the therapy methods used were among the issues highlighted.

Allegations of misconduct and bias in the trials have also raised doubts, leading the FDA to conduct further investigations into these claims. With only two FDA-approved treatments for PTSD currently available, the potential approval of MDMA would mark a significant advancement in mental health care, paving the way for broader access to psychedelics.

Positive clinical data presented by Lykos emphasized the reductions in PTSD symptoms and functional impairment among patients who received MDMA treatment. However, the discussion during the meeting focused on challenges such as “functional unblinding” and the lack of data on how patients experienced the acute effects of the drug, crucial factors for evaluating its abuse potential.

Further scrutiny of long-term data from the trials revealed potential issues with drop-out rates, participants seeking therapy independently, and concerns about adverse events not being reported. The controversy surrounding allegations of misconduct, bias, and inappropriate conduct during the trials has sparked widespread debate among panel members and experts contributing to the advisory process.

As the FDA reviews the evidence presented and feedback from the advisory panel, the future of MDMA as a treatment for PTSD remains uncertain. The discussions and investigations sparked by the panel’s findings will play a crucial role in shaping the agency’s ultimate decision on the drug’s potential approval.