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Potential for Aerosol Generation

Last Updated: 01/20/2025

SUMMARY  

  • SPRAVATO nasal spray is intended for administration by the patient under the 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 to allow medication to be absorbed.1
  • To prevent loss of medication, do not prime the device before use.1
  • SPRAVATO is an aqueous solution of esketamine HCl and is not a pulmonary aerosol. Pulmonary aerosols are characterized in part by their percentage of fine particles (<5 µm) needed for delivery of medication to the lungs.2,3 In contrast, SPRAVATO, with its larger particle size is intended to deliver medication into the nasal cavity.4
  • Because of the product characteristics of SPRAVATO, the potential for aerosol generation following nasal administration of SPRAVATO has not been studied, however:
    • SPRAVATO was designed to minimize the percentage of small droplets (<10µm).5
    • If accidentally sprayed into the air, it is estimated that the contents may extend to approximately 500-600 mm (about 20-24 inches).5
  • As per the INSTRUCTIONS FOR USE (IFU), patients are instructed to only spray into the nostril.1 As such, the liquid droplets should stay inside the nasal cavities after the patient sprays the device.
    • The patient should be instructed to sniff gently after spraying to keep the medication inside the nose.
    • The correct positioning of the nasal spray device by the patient is aided with a nose rest. The nose rest is designed to position the spray tip for optimal spray delivery into the nasal cavity.

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 03 January 2025.

References

1 Center for Drug Evaluation and Research. Other Review. NDA 211243 - SPRAVATO (esketamine) - Reference ID: 4398871. 2019-[cited 2025 January 03]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211243Orig1s000OtherR.pdf.  
2 Haddrell AE, Lewis D, Church T, et al. Pulmonary aerosol delivery and the importance of growth dynamics. Ther Deliv. 2017;8(12):1051-1061.  
3 Lavorini F, Buttini F, Usmani OS. 100 years of drug delivery to the lungs. Handb Exp Pharmacol. 2019;260:143-159.  
4 Center for Drug Evaluation and Research. Clinical Pharmacology and Biopharmaceutics Review(s). NDA 211243 - SPRAVATO (esketamine) - Reference ID: 4398871. 2019-[cited 2025 January 03]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211243Orig1s000ClinPharmR.pdf
5 Esketamine. Internal Communication.