SUMMARY

• Across the phase 3 clinical trial program for SPRAVATO nasal spray in treatment-resistant depression, patients with any anatomical or medical condition that, per the investigator’s clinical judgment based on assessment, may impede delivery or absorption of the intranasal drug, were excluded.^1-6
• If a patient has nasal congestion on the dosing day, an intranasal decongestant can be used to reduce congestion. If an intranasal decongestant is used to reduce congestion, it cannot be used within 1 hour prior to intranasal study drug dosing.^7,8

clinical Data

Open-label Study in Allergic Rhinitis Patients and Healthy Subjects

Zannikos et al (2023)⁸ conducted an open-label study to evaluate the pharmacokinetics of esketamine produced by a single, 56-mg intranasal dose of esketamine in healthy subjects and patients with allergic rhinitis. The mean maximum serum concentration (C_max) and area under the plasma concentration-time curve (AUC) of esketamine were 21 and 14%, respectively, higher in patients with allergic rhinitis compared to control subjects. However, these differences in pharmacokinetics were smaller than the intersubject variability in C_max and AUC values for the control group and, therefore, were not expected to be clinically important. Furthermore, pretreatment with mometasone in healthy subjects and oxymetazoline in patients with rhinitis one hour before esketamine administration did not affect the pharmacokinetics of esketamine.

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 15 March 2024.