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Use of SPRAVATO in Rhinitis or Nasal Congestion

Last Updated: 11/22/2024

SUMMARY

  • A pharmacokinetic (PK) study conducted in patients with allergic rhinitis (including runny nose, itchy nose, nasal congestion, and sneezing) who were administered 56 mg SPRAVATO, found that the maximum serum concentration (Cmax) and area under the curve (AUC) of esketaminewere 21 to 14% higher than in control subjects without allergic rhinitis. These differences in PK are not expected to be clinically important since they are smaller than the variability in Cmax and AUC values between patients in the control group.1
  • Patients who require a nasal corticosteroid or nasal decongestant on a dosing day should administer these medications at least 1 hour before administration of SPRAVATO.1,2
  • In addition, as part of the instructions for use on the day of dosing, patients are advised to blow their nose prior to using the first SPRAVATO device only.3

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 12 November 2024.

References

1 Zannikos P, Solanki B, De Meulder M, et al. Pharmacokinetics of nasal esketamine in patients with allergic rhinitis with and without nasal decongestant pretreatment and in healthy subjects with and without nasal corticosteroid pretreatment. Clin Pharmacokinet. 2023;62(9):1315-1328.  
2 Center for Drug Evaluation and Research. Clinical Pharmacology and Biopharmaceutics Review(s). NDA 211243 - SPRAVATO (esketamine) - Reference ID: 4398871. 2019- [cited 2024 November 12]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211243Orig1s000ClinPharmR.pdf
3 Center for Drug Evaluation and Research. Other Review(s). NDA 211243 - SPRAVATO (esketamine) - Reference ID: 4398871. 2019- [cited 2024 November 12]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211243Orig1s000OtherR.pdf