FDA Rejects MDMA-Assisted Therapy for PTSD, Citing Insufficient Evidence

Lykos Therapeutics faces major setbacks as it plans additional trials to meet FDA requirements for approval.

MDMA-assisted therapy was denied FDA approval due to concerns over trial design and evidence quality.
Lykos Therapeutics must conduct another Phase 3 trial to address FDA's concerns, delaying potential approval.
Three research papers by Lykos were retracted for protocol violations, raising further ethical questions.
Lykos has cut staff and appointed a new chief medical adviser to navigate the regulatory challenges.
Other companies are exploring psychedelic treatments without psychotherapy to simplify approval processes.