In August 2024, the FDA (the US drug regulator) rejected the first application to approve MDMA as a treatment for PTSD (post-traumatic stress disorder). The agency had concerns about participants knowing they were on the real drug, the potential for abuse, and problems with how the trials were run. To reapply, the company needs to run new large-scale trials, which will take years.
After the August 2024 FDA rejection of Lykos's MDMA-PTSD application citing unresolved unblinding, abuse-potential, and trial-conduct concerns, a new application requires additional Phase 3 data unlikely to complete and clear review within this timeframe. No approval is the base case.