BPL-003 Phase 2b Clinical Trial Results - The open-label extension of the BPL-003 Phase 2b clinical trial demonstrated additional and durable antidepressant effects after a second dose[11] - Patients who received an active dose (either 8 mg or 12 mg) of BPL-003 in the core study achieved a response rate of 63% and a remission rate of 48% at Week 8 (Week 16 of the Phase 2b clinical trial)[11] - In the core study, statistically significant MADRS difference was observed at Day 29 (Week 4) following a single 8 mg or 12 mg dose vs 0.3 mg[21] - In the core study, 8 mg dose demonstrated comparable efficacy to 12 mg, suggesting it may be sufficient to achieve maximal therapeutic benefit[21] - In the OLE study, patients who received an active dose in the core study showed a mean reduction in MADRS score of 19.0 points at Day 57 compared to baseline at the start of the Phase 2b clinical trial[36] - In the OLE study, responder rates continued to improve following a second dose of BPL-003[37] - In the OLE study, remission rates continued to improve following a second dose of BPL-003[40] Safety and Tolerability - BPL-003 was generally well-tolerated, with the majority of TEAEs occurring on the day of dosing, classified as mild or moderate, and transient in nature[11] - In the core study, 78% of participants experienced any TEAE[24] - In the OLE study, 86% of participants experienced any TEAE[43] Market Opportunity - Spravato achieved blockbuster status and established the 2-hour in-clinic interventional psychiatry treatment paradigm[50] - Spravato reported global annual sales of $1.047 billion in Q1-Q3 2025[51]