Efficacy

With SPRAVATO® (esketamine) your adult patients with TRD 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 oral AD demonstrated superior improvement in depression symptoms compared to placebo plus oral AD at Week 4 for adults with TRD1,2

TRD Primary Short-term Chart
  • Most of the treatment difference between SPRAVATO® and placebo was observed at 24 hours
  • Between 24 hours and Day 28, both SPRAVATO® and placebo groups continued to improve
  • The difference between the groups generally remained the same but did not appear to increase over time through Day 28

AD=antidepressant.

LS=least-squares.

MADRS=Montgomery-Åsberg Depression Rating Scale.

Demonstrated superior improvement in depression symptoms at Week 4 for adults with TRD1,2

TRD Study 1 Short-term Design

Primary Endpoint

  • Change from baseline (Day 1) to endpoint (Day 28) in Montgomery-Åsberg Depression Rating Scale (MADRS) score

Flexible Dosing

  • Patients (aged 18-64 years) were randomized to receive twice-weekly doses of SPRAVATO® (flexible dose; 56 mg or 84 mg) plus a newly initiated oral AD or intranasal placebo plus newly initiated oral AD
  • Dosages could be titrated to 84 mg or maintained on 56 mg, and were adjusted on Day 4, 8, 11, or 15
  • Dosages remained stable after Day 15

Oral Antidepressant

  • A newly initiated open-label oral AD (SSRIs: escitalopram, sertraline; SNRIs: duloxetine, venlafaxine extended-release) was initiated on Day 1
  • The selection of the newly initiated oral AD was determined by the investigator based on patient’s prior history

Demographics and Baseline Characteristics

  • Median age 47 years; 62% female; 93% Caucasian; 5% Black

Secondary descriptive endpoints: TRD response and remission rates at Week 41,2

TRD Secondary short-term Chart
  • Response was defined as an improvement of at least 50% from baseline in total MADRS score
  • Remission was defined as a MADRS total score of ≤12

*All subjects taking SPRAVATO® started on 56 mg on Day 1. Dose adjustment was made on prespecified days based on clinical judgment.

Significantly delayed time to relapse in a long-term maintenance trial in adults with TRD with stable remission1,3

TRD Long-term remission chart

SPRAVATO® plus oral AD significantly delayed time to relapse compared to placebo plus oral AD in a long-term maintenance trial in patients with stable remission1,3*

  • Stable remission was defined as a MADRS total score of ≤12 in at least 3 of the last 4 weeks of the optimization phase

*Relapse was defined as a MADRS total score of ≥22 for 2 consecutive weeks and/or hospitalization for worsening depression, or any other clinically relevant event determined per clinical judgment to be suggestive of a relapse of depressive illness.

AD=antidepressant.

Significantly delayed time to relapse in a long-term maintenance trial in adults with TRD with stable remission1,3

TRD Long-term maintenance Chart

In a long-term maintenance trial in patients with TRD with stable response, SPRAVATO® plus oral AD significantly delayed time to relapse compared to placebo1,3*

  • Stable response was defined as a MADRS total score reduction of ≥50% from baseline in each of the last 2 weeks of the optimization phase but does not meet criteria for stable remission

*Relapse was defined as a MADRS total score of ≥22 for 2 consecutive weeks and/or hospitalization for worsening depression, or any other clinically relevant event determined per clinical judgment to be suggestive of a relapse of depressive illness.

Significantly delayed time to relapse in a long-term maintenance trial in adults with TRD with stable remission1,3

TRD Study 2 Long-term Design

Primary Endpoint

  • Time to relapse (cumulative distribution) during the maintenance phase among patients in stable remission
    • Relapse was defined as one of the following:
      • MADRS total score of ≥22 for 2 consecutive weeks
      • Hospitalization for worsening depression, or any other clinically relevant event determined per clinical judgment to be suggestive of a relapse of depressive illness

Secondary Endpoint

  • Time to relapse (cumulative distribution) during the maintenance phase among patients in stable response

Enrollment

  • 437 patients (aged 18-64 years) were directly enrolled
    • Patients who were directly enrolled received SPRAVATO® (56 mg or 84 mg twice/week) plus a new oral AD in a 4-week open-label induction phase before entering a 12-week optimization phase
  • 268 patients (aged 18-64 years) were transferred from short-term studies

Demographics and Baseline Characteristics

  • Median age 48 years (range 19-64 years); 66% female; 90% Caucasian, 4% Black
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References:

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

2. Popova V, 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 [published online May 21, 2019]. Am J Psychiatry. 2019;176(6):428-438. doi:10.1176/appi.ajp.2019.19020172

3. Daly EJ, et al. Efficacy of esketamine nasal spray plus oral antidepressant treatment for relapse prevention in patients with treatment-resistant depression: a randomized clinical trial [published online June 5, 2019]. JAMA Psychiatry. 2019;76(9):893-903. doi:10.1001/jamapsychiatry.2019.1189