Efficacy SMDD

With SPRAVATO® (esketamine), your adult patients with depressive symptoms of MDSI may find the efficacy they’ve been seeking

Actor portrayal.

TRD=treatment-resistant depression in adults.

MDSI=depressive symptoms in adults with MDD with acute suicidal ideation or behavior.

SPRAVATO® (esketamine) plus SOC demonstrated a rapid reduction of depressive symptoms with superior improvement at 24 hours compared to placebo plus SOC for adults with MDSI1,2

Pooled Analysis
  • The treatment difference of SPRAVATO® compared to placebo was rapid, appearing as early as 4 hours
  • Between 4 hours and Day 25, both the SPRAVATO® and placebo groups continued to improve; the difference between the groups generally remained but did not appear to increase over time through Day 25

LS=least squares.

MADRS=Montgomery-Åsberg Depression Rating Scale.

SOC=comprehensive standard of care (initial hospitalization and a newly initiated or optimized oral antidepressant).

MDSI Study Design1,2

Evaluated in short-term (4-week), randomized, double-blind, multicenter, placebo-controlled studies, Study 3 and Study 4, in adults with moderate-to-severe MDD (MADRS total score >28) who had active suicidal ideation and intent. Primary endpoint was reduction of severity of depression symptoms of MDD as measured by the change from baseline MADRS total score at 24 hours.1,2

MDSI Study Design

Comprehensive SOC treatment included an initial inpatient psychiatric hospitalization and a newly initiated or optimized oral antidepressant (AD) (AD monotherapy or AD plus augmentation therapy) as determined by the investigator. After completion of the 4-week treatment period with SPRAVATO®/placebo, study follow-up continued through Day 90.

  • SPRAVATO® was studied in 449 adult patients with moderate to severe MDD who had active suicidal ideation with intent, across all studies1

Primary Endpoint

  • Reduction of severity of depressive symptoms of MDD as measured by the change from baseline MADRS total score at 24 hours after first dose (Day 2)

Dosing

  • Patients received treatment with SPRAVATO® 84 mg or placebo nasal spray twice weekly for 4 weeks
  • After the first dose, a one-time dose reduction to SPRAVATO® 56 mg was allowed for patients unable to tolerate the 84-mg dose

Limitations of Use

  • The effectiveness of SPRAVATO® in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO® does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO®
  • SPRAVATO® is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO® as an anesthetic agent have not been established
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References:

1. SPRAVATO® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. July 2020.

2. 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. doi:10.4088/JCP.19m13191