Real-World Safety Profile of Esketamine Nasal Spray During the First 12 Treatment Sessions: An Analysis at 34 Months After Approval

Abstract: Purpose: To examine real-world esketamine nasal spray (ESK) treatment-emergent adverse events (TEAEs) of interest (i.e., sedation, dissociation, increased blood pressure [BP]) and serious adverse events (SAEs) during the first 12 treatment sessions. Methods: ESK Risk Evaluation and Mitigation Strategy patient monitoring forms were evaluated to summarize key safety findings for the first 34 months (March 5, 2019 to January 5, 2022) after product approval, with a focus on treatment sessions 1-12. TEAE rates reflect the percentage of patients who experienced ≥1 TEAE during the treatment phase. Results: A total of 19,151 patients had ≥1 ESK treatment session during the evaluation period. Cumulative rates of ESK TEAEs of interest in sessions 1-8 and sessions 9-12 were 61.2% and 50.3% for sedation, 64.8% and 54.1% for dissociation, and 6.9% and 3.3% for increased BP, respectively. Rates of TEAEs of sedation and dissociation were consistent over the first 12 treatment sessions. SAEs (determined by reporter) occurred in ≤1.6% of patients (first session, 0.5%; sessions 1-8, 1.6%; sessions 9-12, 0.5%); ≤0.2% resulted in hospitalization (first session,