FDA Rejects MDMA for PTSD Treatment, Requests More Trials

The decision raises questions about the future of psychedelic therapies in the U.S. medical system.

Overview

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.