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

Adverse Event of SPRAVATO – Sexual Dysfunction

Last Updated: 10/28/2024

Summary

During 3 short-term, double-blind, phase 3 studies¹^–³ of SPRAVATO plus a newly initiated oral antidepressant (AD) (duloxetine, escitalopram, sertraline, or venlafaxine XR) vs AD plus placebo (PBO) and 1 short-term, double-blind, phase 2 study⁴ of adjunctive SPRAVATO in patients with treatment-resistant depression, the incidence of treatment-emergent adverse events (TEAEs) related to sexual function was⁵:
- Ejaculation delayed (SPRAVATO+AD): 0.2% (1/502 patients) vs AD+PBO: 0%
- Erectile dysfunction (SPRAVATO+AD): 0% vs AD+PBO: 0.6% (2/341 patients)
- Sexual dysfunction (SPRAVATO+AD): 0.2% (1/502 patients) vs AD+PBO: 0%
During the maintenance phase of a double-blind maintenance of effect study,⁶ the incidence of TEAEs related to sexual function was⁵:
- Sexual dysfunction (SPRAVATO+AD): 0% vs AD+PBO: 0.7% (1/145 patients)
During the open-label phases of SPRAVATO+AD in a phase 2 adjunctive study,⁴ maintenance of effect study⁶ (direct entry patients from induction and optimization phases), and long-term safety study,⁷ the incidence of TEAE related to sexual function was⁵:
- Sexual dysfunction: 0.4% (6/1335)
- Erectile dysfunction: 0.3% (4/1335)
- Priapism: 0.1% (1/1335)

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 20 September 2024.

References

Show

1	Fedgchin M, Trivedi M, Daly EJ, et al. Efficacy and safety of fixed-dose esketamine nasal spray combined with a new oral antidepressant in treatment-resistant depression: results of a randomized, double-blind, active-controlled study (TRANSFORM-1). Int J Neuropsychopharmacol. 2019;22(10):616-630.
2	Ochs-Ross R, Daly EJ, Zhang Y, et al. Supplement to: Efficacy and safety of esketamine nasal spray plus an oral antidepressant in elderly patients with treatment-resistant depression - TRANSFORM-3. Am J Geriatr Psychiatry. 2020;28(2):121-141.
3	Popova V, Daly EJ, M T, et al. Efficacy and safety of flexibly dosed esketamine nasal spray combined with a newly initiated oral antidpressant in treatment-resistant depression: a randomized double-blind active-controlled study. Am J Psychiatry. 2019;176(6):428-438.
4	Daly EJ, Singh JB, Fedgchin M, et al. Efficacy and safety of intranasal esketamine adjunctive to oral antidepressant therapy in treatment-resistant depression: a randomized clinical trial. JAMA Psychiatry. 2017;75(2):139.
5	Data on File. Esketamine. Integrated Summary of Safety - TRD. Janssen Research & Development, LLC; 2018.
6	Daly EJ, Trivedi MH, Janik A, et al. Efficacy of esketamine nasal spray plus oral antidepressant treatment for relapse prevention in patients with treatment-resistant depression: a randomized clinical trial. JAMA Psychiatry. 2019;76(9):893-903.
7	Wajs E, Aluisio L, Holder R, et al. Esketamine nasal spray plus oral antidepressant in patients with treatment-resistant depression: assessment of long-term safety in a phase 3, open-label study (SUSTAIN-2). J Clin Psychiatry. 2020;81(3):19m12891.