Real-World Use of Esketamine Nasal Spray at 46 Months: Characterizing Healthcare Settings, Prescribers, Pharmacies, Patients, and Key Safety Data

Abstract: Background: Upon approving esketamine nasal spray (ESK) in conjunction with an oral antidepressant for treatment-resistant depression in adults, the FDA required a Risk Evaluation and Mitigation Strategy (REMS) to mitigate the risks of serious adverse outcomes resulting from sedation, dissociation, and abuse/misuse. We summarize REMS findings and those from Janssen’s Global Medical Safety (GMS) database here.

Methods: Healthcare settings (HCS), prescribers, pharmacies, patients, and key safety data were characterized using data solicited from the REMS and reported to GMS databases, which include the first 46 months (March 5, 2019-January 5, 2023) of post-approval ESK use.

Results: Of 34,110 patients with ≥1 ESK treatment session during this time, 63.2% were aged 30-59 years, 60.4% were female, and 26,965 (79.1%) reported ≥1 adverse event (AE). Across 815,172 treatment sessions, dissociation and sedation occurred in 42.3% and 36.6% of sessions, respectively; most events resolved within 2 hours (99.2% and 98.7%, respectively). There were 440,369 cases of AEs in the US GMS database. After follow-up,  < 0.2% of events and  < 0.4% of cases were confirmed as serious in REMS and GMS databases, respectively. A total of 5675 HCS were certified during the reporting period. Per REMS, most prescribers initiating patients on ESK specialized in psychiatry (89.1%) and had MD/DO credentials (74.4%). Of 3581 pharmacies certified during the reporting period, 1120 (31.3%) self-identified as outpatient.

Conclusions: Of the AEs in the REMS and GMS databases,  < 0.5% cases were confirmed as serious. Overall key safety characteristics were consistent with ESK US prescribing information and previous clinical studies.Short Description: Data from the ESK REMS program and Janssen's GMS databases were utilized to summarize key safety data and operational characteristics related to ESK treatment throughout the 46 months following FDA approval. The most common AEs reported were sedation and dissociation. Notably, HCPs in the outpatient setting are asked to record whether either of these events occur during treatment sessions through solicited reporting. Overall safety characteristics were consistent with ESK’s established safety profile.Name of Sponsoring Organization(s): Janssen Scientific Affairs, LLC