FDA rejects MDMA as a treatment for PTSD despite advocacy from veteran organizations. Another Phase 3 trial is requested to confirm safety and efficacy. Companies plan to appeal the decision.
Key Points
FDA rejects MDMA as PTSD treatment
Veteran organizations advocate for psychedelic-assisted therapies
Request for another Phase 3 trial
Companies plan to appeal the decision
Pros
Advocacy for novel PTSD treatments
Potential benefits of psychedelic-assisted therapies in mental health challenges
Cons
Significant limitations in the data for FDA approval