FDA Rejects PTSD Treatment, Citing Data Concerns

The decision delays the approval of the first psychedelic drug for PTSD, requiring further studies to ensure safety and efficacy.

Lykos Therapeutics' application for MDMA-assisted therapy was declined due to significant data limitations.
The FDA has requested another Phase 3 trial, which could take several years to complete.
Veterans and mental health advocates express disappointment, citing the urgent need for new PTSD treatments.
Concerns included potential bias in clinical trials and allegations of misconduct.
The FDA remains open to further research and development in psychedelic therapies for mental health.