FDA Advisory Panel Rejects Lykos’ MDMA Treatment for PTSD Despite Promising Results

1. Rejection by FDA Committee: The FDA's Psychopharmacologic Drugs Advisory Committee voted 9-2 against the effectiveness of Lykos Therapeutics' MDMA treatment for post-traumatic stress disorder (PTSD) and 10-1 against the benefits outweighing the risks.
2. Concerns Over Data: Panelists cited gaps in data, potential for abuse or misconduct, and lack of racial diversity among participants as reasons for their decision.
3. Promising Results: Despite the rejection, the treatment showed significant improvement in PTSD symptoms, with 86% of participants experiencing "clinically meaningful" improvement and 71% no longer meeting diagnostic criteria for PTSD.
4. FDA Decision: The FDA will make a final ruling on the treatment by August 11, although the committee's recommendation is not binding.
5. Potential Impact: The treatment could potentially help millions of people suffering from PTSD, including veterans, if approved.