COMP360 Safety Data in Phase 3 TRD Trials, With Steve Levine, MD

COMP360 psilocybin in Phase 3 TRD trials shows a mostly transient and tolerable safety profile under supervised, episodic dosing. Most treatment-emergent adverse events were reported on dosing day, generally mild to moderate, and typically resolved within 24 hours. Reported side effects included headache, nausea, fatigue, anxiety, and visual hallucinations, with adverse events described as dose-dependent but improving by the following day. Suicidality remained a key focus in TRD, and the data reported no imbalance in suicidal ideation or behavior between treatment arms, with under 1% suicidality reports. The discussion also covers practical retreatment and scalability questions, including evidence suggesting benefit lasting up to about 6 months in responders after 1 or 2 administrations. Levine frames the potential future model as episodic rather than maintenance-based and points to certified infrastructure used for esketamine nasal spray sites as a possible foundation for supervised delivery.