SUMMARY

• The pharmacokinetics of esketamine nasal spray were evaluated in a phase 1 study.¹ Based on this data, a dosage adjustment is not required in patients with renal impairment.²
• There is no clinical experience with SPRAVATO administered as a nasal spray in patients on renal dialysis.²

CLINICAL DATA

The pharmacokinetics and safety of a single, 28-mg dose of esketamine nasal spray in patients with varying stages of renal impairment compared to healthy patients was evaluated in a phase 1, open-label, single-dose, parallel-group study (N=32).¹

• Mild impairment: measured creatinine clearance (CL_CRm) 58 to 77 mL/min (n=8)
• Moderate impairment: CL_CRm 30 to 47 mL/min (n=8)
• Severe impairment: CL_CRm 5 to 28 mL/min (n=8)
• Normal, with no evidence of kidney damage: CL_CRm 88 to 140 mL/min (n=8)

Results

• Esketamine systemic exposure was slightly higher in patients with mild to severe renal impairment relative to patients with normal renal function.
• Compared to patients with normal renal function, the maximum serum concentration (C_max) of esketamine was, on average, 20 to 26% higher in patients with mild, moderate, or severe renal impairment.
• Esketamine area under the curve (AUC) values were 13 to 36% higher in patients with mild to severe impairment.
• Compared to patients with normal renal function, noresketamine C_max and AUC values were slightly lower in patients with mild renal impairment. The C_max of noresketamine was approximately 15% and 23% higher in patients with moderate and severe impairment, respectively, and AUC values were 39 to 55% higher.
• All treatment-emergent adverse events were mild in severity.

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 13 November 2024.