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Psych Congress  

Adverse Events Affecting Readiness for Discharge From the Clinical Setting After Esketamine Nasal Spray Administration

Authors  

H. Lynn Starr, MD – Janssen Scientific Affairs, LLC, Titusville, NJ; Andrew Winokur, MD, PhD – UConn Health, Farmington, CT; Ella Daly, MB BCh BAO – Janssen Scientific Affairs, LLC, Titusville, NJ; Jagadish Gogate, PhD – Janssen Research and Development, LLC, Titusville, NJ; David Williamson, PhD, MBA – Janssen Scientific Affairs, LLC, Titusville, NJ; Leah Aluisio, B.S, M.S – Janssen Research and Development, LLC, San Diego, CA; Michelle Han, PharmD – Janssen Scientific Affairs, LLC; Sheldon Preskorn, MD – University of Kansas School of Medicine, Wichita, KS

Sponsor  
Janssen Scientific Affairs, LLC

Objective: To describe clinical findings in patients considered not ready for discharge from clinical sites 2 hours after administration of esketamine nasal spray (ESK).

Methods: A pooled analysis of two 4-week phase 3 studies (NCT02417064, NCT02418585) of ESK + newly initiated oral antidepressant (AD) and AD + placebo nasal spray assessed adverse events (AEs) in patients with treatment resistant depression considered not ready for discharge from clinical sites at 2 hours after administration. Per protocol, patients could leave the sites if assessed as clinically stable at 1.5 hours after administration. Relevant AEs were those ongoing at 1.5 and 2 hours after dosing. Vital signs and clinician judgement also determined readiness for discharge.

Results: Of 349 patients randomized to twice-weekly ESK, ≥90% were considered ready for discharge at 90 minutes after administration, with an additional 2%-7% ready at 2 hours. Across the eight ESK treatment sessions, ≤3.5% were considered not ready for discharge at 2 hours after administration. The most common ongoing AEs at 1.5 and 2 hours among patients not ready for discharge at 2 hours were primarily central nervous system (CNS)–related, (e.g., dissociation, somnolence, feeling drunk, hypoaesthesia, vertigo and dizziness) and nausea/dysgeusia.

Conclusion: Overall, ≤3.5% of patients were considered not ready for discharge at 2 hours after esketamine nasal spray administration. AEs were largely CNS-related and consistent with the known safety profile of ESK. Awareness of what to expect after ESK administration on dosing days may help inform clinicians when treating patients with ESK.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.

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