MDMA — Entactogen / serotonin-norepinephrine-dopamine releasing agent (Schedule I)

The FDA's August 2024 rejection was a major setback — advisory committee voted 10-1 against efficacy and 9-2 against safety/risk-benefit, raising concerns about functional unblinding (all participants identify drug vs placebo), data integrity at one trial site, and inability to separate pharmacological effects from therapy effects. The TGA approval in Australia shows regulatory bodies can diverge significantly on identical data. Key clinical point: MDMA + SSRI combination is absolutely contraindicated — serotonin syndrome risk is life-threatening. The therapeutic model requires 3 MDMA sessions embedded in ~12 preparatory and integration therapy sessions; the pharmacology alone cannot be separated from the therapeutic container.