Lykos Faces Setback as ICER Concludes Insufficient Evidence for MDMA-Based PTSD Treatment

1. ICER's Conclusion: The Institute for Clinical and Economic Review (ICER) has concluded that the publicly available evidence for Lykos Therapeutics' MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD) is insufficient to assess its overall net benefit.
2. Clinical Trial Concerns: ICER cited functional unblinding, trial design, and conduct issues as reasons for the insufficient evidence rating.
3. FDA Advisory Committee: The FDA advisory committee voted 9-2 against endorsing MDMA-assisted therapy for PTSD due to concerns over the clinical research, including potential bias and misconduct.
4. Lykos' Response: Lykos presented positive findings from two randomized controlled trials, but the results were marred by controversies such as functional unblinding and lack of data on acute effects and abuse potential.
5. Implications: The outcome may impact the broader effort to expand access to psychedelics and the potential approval of MDMA-assisted therapy for PTSD.