Medical inquiries

Connect with my medical science liaison

Chat live

Available Monday - Friday 9AM - 4:30PM ET

Call me now

Available Monday - Friday 9AM - 7:30PM ET

Email your inquiry

Call 1-800-526-7736

Available Monday - Friday 9AM - 8PM ET

Live video

Available Monday - Friday 9AM - 4:30PM ET

This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

SPRAVATO® (esketamine)

Medical Information

+ Save link

Use of SPRAVATO in Pain

Last Updated: 07/29/2024

SUMMARY

SPRAVATO has not been studied and is not indicated for the treatment of pain.
Analyses of health-related quality of life (HRQoL) outcomes from TRANSFORM-2 in patients with treatment-resistant depression (TRD) and pooled data from ASPIRE-1 and -2 in patients with major depressive disorder and active suicidal ideation with intent (MDSI) found a numerically lower percentage of patients who reported impairment in the pain/discomfort dimension of the European Quality of Life Group-5 Dimension-5 Level (EQ-5D-5L) with SPRAVATO+oral antidepressant (oral AD) vs placebo (PBO)+oral AD.¹^,²

CLINICAL DATA

Jamieson et al (2023)¹^,² analyzed data from TRANSFORM-2³, a phase 3 double-blind study in TRD, and pooled data from ASPIRE-1⁴ and 2⁵, phase 3 studies in MDSI, to assess HRQoL outcomes in patients treated with SPRAVATO.

Methods

One patient-reported outcome scale used in the study was the EQ-5D-5L, which consisted of the EQ-5D descriptive system and the EQ-Visual Analogue Scale (EQ-VAS) score.¹^,²
- The descriptive system comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
- Each dimension was scored on 5 levels: L1, no problems; L2, slight problems; L3, moderate problems; L4, severe problems; and L5, extreme problems.

TRANSFORM-2 Results

The full analysis set included 223 patients (SPRAVATO+oral AD, n=114; PBO+oral AD, n=109; mean [standard deviation] age, 45.7 [11.89] years).¹
On Day 28, a numerically lower percentage of patients reported impairment in the SPRAVATO+oral AD group vs the PBO+oral AD group in all 5 EQ-5D-5L dimensions, including pain/discomfort (35.6% vs 54.0%).¹ See Table: EQ-5D-5L Individual Dimension of Pain/Discomfort - Percentage of Patients Reporting Impairment in SPRAVATO+Oral AD and PBO+Oral AD Groups in TRANSFORM-2.

EQ-5D-5L Individual Dimension of Pain/Discomfort - Percentage of Patients Reporting Impairment in SPRAVATO+Oral AD and PBO+Oral AD Groups in TRANSFORM-2¹

SPRAVATO+Oral AD (%)			PBO+Oral AD (%)			% Difference (95% CI)
Baseline (n=114)	Day 15 (n=111)	Day 28 (n=104)	Baseline (n=109)	Day 15 (n=104)	Day 28 (n=100)	Day 15	Day 28
68.5	52.3	35.6	74.3	59.6	54.0	-7.4 (-20.6 to 5.9)	-18.4 (-31.8 to -5.0)
Abbreviations: AD, antidepressant; CI, confidence interval; EQ-5D-5L, European Quality of Life Group-5 Dimension-5 Level; PBO, placebo.

Pooled ASPIRE 1 and 2 Results

The full analysis set of the pooled analysis included 451 patients (SPRAVATO+standard of care [SOC]: n=226; mean age, 40.5 years; female, 59.3% and PBO+SOC: n=225; mean age, 39.6 years; female, 62.2%).²
On Day 25, a numerically lower percentage of patients reported impairment in the SPRAVATO+SOC group vs the PBO+SOC group in all 5 EQ-5D-5L dimensions, including pain/discomfort (44.4% vs 52.3%).² See Table: EQ-5D-5L Individual Dimension of Pain/Discomfort - Percentage of Patients Reporting Impairment in SPRAVATO+SOC and PBO+SOC Groups in the ASPIRE 1 and 2 Pooled Analysis.

EQ-5D-5L Individual Dimension of Pain/Discomfort - Percentage of Patients Reporting Impairment in SPRAVATO+SOC and PBO+SOC Groups in the ASPIRE 1 and 2 Pooled Analysis²

SPRAVATO+SOC (%)			PBO+SOC (%)			Relative Risk of Reporting Pain/Discomfort at Day 25 from Levels 2-5^a (95% CI)
Baseline (n=225)	Day 2 (n=219)	Day 25 (n=196)	Baseline (n=224)	Day 2 (n=222)	Day 25 (n=193)
62.2	52.1	44.4	64.7	61.7	52.3	0.85 (0.69-1.04)
Abbreviations: AD, antidepressant; CI, confidence interval; EQ-5D-5L, European Quality of Life Group-5 Dimension-5 Level; PBO, placebo; SOC, standard of care. ^aLevels 2-5 indicated slight to extreme problems Note: SOC comprised of newly optimized oral AD therapy and initial hospitalization

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 11 June 2024. This response is limited to data regarding SPRAVATO and not other formulations of esketamine.

References

Show

1	Jamieson C, Popova V, Daly E, et al. Assessment of health-related quality of life and health status in patients with treatment-resistant depression treated with esketamine nasal spray plus an oral antidepressant. Health Qual Life Outcomes. 2023;21(1):40.
2	Jamieson C, Canuso CM, Ionescu DF, et al. Effects of esketamine on patient-reported outcomes in major depressive disorder with active suicidal ideation and intent: a pooled analysis of two randomized phase 3 trials (ASPIRE I and ASPIRE II). Qual Life Res. 2023;32(11):3053-3061.
3	Popova V, Daly EJ, Trivedi M, et al. Efficacy and safety of flexibly dosed esketamine nasal spray combined with a newly initiated oral antidepressant in treatment-resistant depression: a randomized double-blind active-controlled study. Am J Psychiatry. 2019;176(6):428-438.
4	Fu DJ, Ionescu DF, Li X, et al. Esketamine nasal spray for rapid reduction of major depressive disorder symptoms in patients who have active suicidal ideation with intent: double-blind, randomized study (ASPIRE I). J Clin Psychiatry. 2020;81(3):19m13191.
5	Ionescu DF, Fu DJ, Qiu X, et al. Esketamine nasal spray for rapid reduction of depressive symptoms in patients with major depressive disorder who have active suicide ideation with intent: results of a phase 3, double-blind, randomized study (ASPIRE II). Int J Neuropsychopharmacol. 2021;24(1):22-31.