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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.
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