BPL-003 Nasal Spray Shows Quick and Enduring Effect in Treatment-Resistant Depression

Mebufotenin benzoate intranasal spray (BPL-003) showed rapid and durable antidepressant effects in a small cohort of treatment-resistant depression patients. In cohort 1 of a phase 2a, 12 adults received a single 10 mg intranasal dose and were followed with MADRS assessments at days 2, 8, 29, 57, and 85 (open-label, no concomitant antidepressants). Mean MADRS dropped by 12.6 points as early as day 2, with response (50% or more MADRS reduction) persisting to 12 weeks and remission (MADRS 10 or less) occurring in over 63% at one or more timepoints. Hedonic capacity improved substantially, with Snaith-Hamilton Pleasure Scale falling from 8.4 at baseline to 1.5 at day 85, consistent with reduced anhedonia. Safety and tolerability were described as favorable: no serious adverse events or treatment discontinuations, while mild-to-moderate side effects included transient blood pressure elevations, nausea, and nasal discomfort. Practical feasibility was also highlighted, with most participants discharge-ready within about 90 minutes after dosing. Phase 3 is planned for initiation in Q2 2026.