FDA's Stance on MDMA-Assisted Therapy for PTSD: An Ongoing Journey
The FDA's recent decision to pause the approval of MDMA-assisted therapy for PTSD is a reminder of the complexities in advancing groundbreaking treatments. While the...
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Dr. Scott Fisher
The FDA Panel’s Rejection of MDMA: Not a Stop Sign for the Psychedelic Industry
The team at Segal Trials’ Center for Psychedelic Research closely followed the recent session of the FDA’s Psychopharmacologic Drugs Advisory Committee. This pivotal meeting focused on the New Drug Application (NDA) submitted by Lykos Therapeutics for MDMA-assisted therapy for Post-Traumatic Stress Disorder (PTSD). Despite compelling presentations and data showing significant efficacy and a low incidence of serious adverse events, the committee voted against FDA approval. This vote, however, is non-binding, and the FDA’s final decision is expected by August 11, 2024.