Atai and Beckley Phase 2b success for 5-MeO-DMT nasal spray mebufotenin moves treatment-resistant depression into Phase 3

Mebufotenin, a nasal spray formulation being developed by Atai Life Sciences and Beckley Psytech, shows Phase 2b success in treatment-resistant depression. The companies say the psychedelic mebufotenin safely and significantly reduced symptoms versus a low-dose control, and they plan to advance into Phase 3 testing, with the larger of the two studied doses (8 mg) slated to move forward after consultation with regulators. Improvements reportedly began as early as one day after dosing and generally lasted at least eight weeks, with no serious side effects and no evidence of suicidal intent or behavior. The Phase 2b result is also tied to the companies’ planned merger process and broader investor appetite for psychedelic mental health therapies, including comparisons to intranasal ketamine derivative Spravato.