Long-Term Safety and Efficacy of Esketamine Nasal Spray in Black and/or African American Adults With Treatment-Resistant Depression: A Subgroup Analysis of the SUSTAIN-3 Study

Abstract: Purpose: This subgroup analysis of SUSTAIN-3 (NCT02782104), an ongoing open-label extension study of esketamine nasal spray (ESK), assessed long-term safety and efficacy of flexibly dosed ESK in combination with an oral antidepressant (OAD) in Black and/or African American (Black/AA) patients (aged 18-64 years) diagnosed with treatment-resistant depression (TRD). Methods: Patients previously participating in ≥1 of 5 “parent” studies and entering SUSTAIN-3 in either the 4-week induction phase (IND) or the variable duration optimization/maintenance phase (OP/M) were included. Patients received ESK 56 or 84 mg twice weekly during IND and flexible dosing during OP/M (both with an OAD). Results: As of December 2020, 41 Black/AA patients were included in the analysis (mean age, 47.3 years; not Hispanic/Latino, 90.2%; female, 68.3%); 31.7% of patients had ≥36 months of ESK exposure. The most common TEAEs were dizziness (31.7%), dissociation (26.8%), and nausea (24.4%). Most TEAEs were mild/moderate in severity. Most AEs of dissociation, sedation, nausea, and elevated blood pressure that occurred on a dosing day resolved on the same day. At IND baseline, mean MADRS, PHQ-9, and SDS scores were 29.9, 14.5, and 17.4, respectively, consistent with moderately severe illness. Mean (SD) changes during IND were −11.9 (11.06, MADRS), −5.3 (6.88, PHQ-9), and −4.2 (10.54, SDS). Improvements were generally maintained throughout OP/M. Conclusion: Long-term safety of ESK+OAD in Black/AA adults with TRD was consistent with the established safety and tolerability profile of the overall SUSTAIN-3 patient population. Observed improvements in symptom severity and functional impairment were generally maintained with long-term flexible ESK dosing.Short Description: This subgroup analysis of SUSTAIN-3 (NCT02782104), an ongoing open-label extension study of esketamine nasal spray (ESK), assessed long-term safety and efficacy of flexibly dosed ESK in combination with an oral antidepressant (OAD) in Black and/or African American (Black/AA) patients aged 18-64 years diagnosed with treatment-resistant depression (TRD). Long-term safety of ESK+OAD in Black/AA adults with TRD was consistent with established safety profiles. Symptom severity and functional improvements were generally maintained with long-term flexibly dosed ESK.Name of Sponsoring Organization(s): Janssen Scientific Affairs, LLC