FDA Declines MDMA for PTSD Treatment, Requests Further Trials

The decision marks the first time the agency has considered a Schedule I psychedelic for medical use, highlighting ethical and safety concerns.

Lykos Therapeutics' application for MDMA-assisted PTSD therapy was rejected by the FDA, citing insufficient evidence of efficacy and safety.
The FDA recommended an additional Phase 3 clinical trial to address concerns raised by an advisory committee.
Ethical issues and protocol violations in previous studies have further complicated the approval process.
The rejection has led to significant stock price drops for leading psychedelic companies.
Other companies in the psychedelic space remain optimistic about future approvals, with ongoing trials for different compounds.