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- Esketamine nasal spray contains esketamine hydrochloride, the (S)-enantiomer of ketamine and a Schedule III controlled substance under the Controlled Substances Act.1
- SPRAVATO is intended for administration by the patient under the direct supervision of a healthcare professional, using 2 devices (for a 56 mg dose) or 3 devices (for an 84 mg dose), with a 5-minute rest between use of each device.2
- Because of the risks of sedation and dissociation, patients must be monitored for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting.2
- Since SPRAVATO is administered in the presence of healthcare professionals, the potential for overdose is low.3
- Across clinical trials, there have been no reported cases of overdose with SPRAVATO. The clinical trial program included safety data for 2,283 subjects who received at least 1 dose across completed phase 1, phase 2, and phase 3 studies. Two completed phase 1 studies in healthy volunteers included subjects that received doses higher than the maximum prescribed dose of 84 mg. The maximum dose tested in those 2 studies was 112 mg.3
- In one phase 1 study (14 subjects), the incidence of treatment-emergent adverse events (TEAEs) having at least 3 reported events in the esketamine (ESK) 112 mg group was >2 times higher than in the ESK 84 mg group for dizziness postural, head discomfort, feeling hot, and hyperhidrosis.3
- In another phase 1 study (37 subjects), the incidence of the following TEAEs was reported in at least 3 subjects were >2 times higher in the ESK 112 mg group compared to the ESK 84 mg group: dizziness and nasal congestion.3 This study also showed that the 112 mg group experienced much higher scores for “hallucinating”, “floating”, “detached”, and “spaced out” measures than in the 84 group at 1 hour postdose.2
- A multidimensional analysis evaluating the abuse potential of SPRAVATO reported 8 cases of overdose (including 3 cases of intentional overdose) from the United States (US) Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.4
- Due to the limitations of the FAERS database, a causal relationship cannot be established, and reports do not always contain enough detail to properly evaluate an event. There may also be duplicate reports; therefore, the incidence of an AE cannot be determined.5
- There is no specific antidote for SPRAVATO overdose. In the case of overdose, the possibility of multiple drug involvement should be considered. Contact a Certified Poison Control Center for the most up-to-date information on the management of overdosage (1-800-222-1222 or www.poison.org).
A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on
02 March 2022.
|1|| SPRAVATO (esketamine nasal spray) [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc; https://imedicalknowledge.veevavault.com/ui/approved_viewer?token=7994-21c864d4-b928-49c5-b101-4d34e95f2be3.|
|2|| Center for Drug Evaluation and Research. Other Review. NDA 211243 - SPRAVATO (esketamine) - Reference ID: 4398871. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211243Orig1s000OtherR.pdf. Published July 5, 2019. Accessed March 22, 2022.|
|3|| Data on File. Esketamine. Integrated Summary of Safety - TRD. Janssen Research & Development, LLC. EDMS-ERI-155147726. 2018.|
|4|| Baudot J, Soeiro T, Tambon M, et al. Safety concerns on the abuse potential of esketamine: Multidimensional analysis of a new anti-depressive drug on the market. [published online ahead of print December 15, 2021]. Fundam Clin Pharmacol. doi:10.1111/fcp.12745.|
|5|| United States Food and Drug Administration (USFDA). Questions and answers on FDA's adverse event reporting system (FAERS). June 4, 2018. https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers. Accessed March 4, 2022.|