Efficacy

Your adult patients with TRD may find the efficacy they've been seeking

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Superior improvement in depression symptoms vs oral antidepressant (AD) plus placebo at Week 41,2

short-term chart

Study 1 (N=223) was a pivotal Phase 3, short-term (4-week), randomized, double-blind, multicenter, placebo-controlled trial of adult patients with treatment-resistant depression (TRD)1,2

TRD study1

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
  • First dose is 56 mg. After the first dose, 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

Delayed time to relapse for your adult patients with TRD

SPRAVATO® plus an oral AD significantly delayed time to relapse in a long-term maintenance trial for patients with TRD1,3*

long-term chart

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

Stable response was defined as a MADRS total score reduction ≥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 assessments separated by 5 to 15 days 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.

Study 2 (N=705) was a pivotal Phase 3, long-term, randomized, double-blind, parallel-group, controlled, multicenter maintenance-of-effect study of variable duration of adult patients with treatment-resistant depression (TRD)1,3

TRD Study2

Primary Endpoint

  • Time to relapse (cumulative distribution) during the maintenance phase among patients in stable remission
    • Relapse was defined as one of the following:
      • Relapse was defined as a MADRS total score of ≥22 for 2 consecutive assessments separated by 5 to 15 days
      • Hospitalization for worsening depression, or any other clinically relevant event determined per clinical judgment to be suggestive of a relapse of depressive illness

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
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Next: Safety and tolerability

Learn more

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