FDA Rejects PTSD Treatment, Requests More Trials
The decision raises questions about the future of psychedelic therapies in the U.S. medical system.
- Lykos Therapeutics must conduct another Phase 3 trial to address FDA concerns.
- The FDA's decision was influenced by issues with trial design and potential biases.
- Researchers are disappointed, citing the need for new PTSD treatments.
- Other companies are reconsidering the inclusion of psychotherapy in their psychedelic trials.
- The ruling may impact the approval process for other psychedelics like psilocybin and LSD.