Actor portrayal.
Gradient

TRD Efficacy & Safety

Over 100,000 patients in the US have received treatment with SPRAVATO® as shown below in short-term (as early as 24 hours) and long-term (up to 5 years) studies.1

TRD=treatment-resistant depression in adults (for patients with MDD who have had an inadequate response to 2 or more oral ADs).

Reduction in the burden of depressive symptoms in as early as 1 day

SPRAVATO® demonstrated a rapid and superior improvement in depressive symptoms at 4 weeks (primary endpoint) and at 24 hours (key secondary endpoint) vs placebo2,3

SPRAVATO® primary and key secondary endpoints chartSPRAVATO® primary and key secondary endpoints chart

Primary endpoint

  • Mean MADRS total score decreased from baseline to Day 28, showing statistically significant improvement with individual doses of SPRAVATO® vs placebo (2-sided, P<0.001). The LS mean difference between SPRAVATO® and placebo was -5.1 (95% CI, -7.9 to -2.3) for 56 mg and -6.8 (-9.5; -4.1) for 84 mg4

Key secondary endpoint

  • Significantly greater improvement was noted in the SPRAVATO® 56-mg group (2-sided, P=0.004) and SPRAVATO® 84-mg group (2-sided, P=0.006) vs placebo. On Day 2, the LS mean difference between SPRAVATO® and placebo was -3.8 (95% CI, -6.3 to -1.2) for 56 mg and -3.4 (95% CI, -6.3 to -1.2) for 84 mg4

Demographics and baseline characteristics

  • Patients had a mean age of 45.4 years; 61.1% female; 86.8% White; 6.6% Black4

DB=double-blind; LS=least squares; MADRS=Montgomery-Åsberg Depression Rating Scale; TRD=treatment-resistant depression

Post hoc results from the Monotherapy Study (Study 3)

Numerical improvement seen across all 10 MADRS items at Day 28

SPRAVATO® monotherapy study (study 3) post hoc results chartSPRAVATO® monotherapy study (study 3) post hoc results chart

SPRAVATO® is indicated for adults with TRD. This study was not powered to draw conclusions for individual items of MADRS and statistical significance has not been established.

LS=least squares; MADRS=Montgomery-Åsberg Depression Rating Scale; TRD=treatment-resistant depression.

Open-Label Descriptive Data

SPRAVATO® open-label-descriptive data chartSPRAVATO® open-label-descriptive data chart

Descriptive summary of secondary endpoints. Not assessed for statistical significance.4

  • After 4 weeks, during the 3-month OL period, patients received SPRAVATO® alone or in combination with standard of care (which could include an oral AD). Note: 1 patient did not receive SPRAVATO® during the 3-month OL phase3
  • For participants who received placebo during the DB phase and started SPRAVATO® (placebo/SPRAVATO®) in the OL phase, the MADRS score reductions were similar to the SPRAVATO® 56 mg/SPRAVATO® 84 mg groups by the end of the OL phase3

AD=antidepressant; DB=double-blind; MADRS=Montgomery-Åsberg Depression Rating Scale; OL=open-label; SE=standard error; USPI=US Prescribing Information.

Study Design5
  • Phase 4, randomized, double-blind (DB), placebo-controlled, multicenter study (NCT04599855) conducted in the United States
SPRAVATO® monotherapy study design infographicSPRAVATO® monotherapy study design infographic

Study Evaluations

  • Primary efficacy endpoint: Change in MADRS total score from baseline to Day 28
  • Key secondary endpoint: Change in MADRS total score from baseline to Day 2 (approximately 24 hours post first dose)
  • Safety: Treatment-emergent adverse events were monitored throughout the study

Statistical Analyses5

Assessments

  • Primary and key secondary endpoints were analyzed using a mixed-effects model with repeated measures and a predefined testing hierarchy to control multiplicity. The model included treatment group, analysis center, antidepressant treatment status (on- or off-treatment) at screening entry, day, and day-by-treatment interaction as fixed terms, and the baseline MADRS total score as a covariate
  • Treatment-emergent adverse events were summarized descriptively by treatment group

Analysis sets

  • Full efficacy analysis set: all randomized participants meeting non-response criteria and who received ≥1 dose of double-blind study medication
  • Safety analysis set: all randomized participants who received ≥1 dose of double-blind study medication

MADRS=Montgomery-Åsberg Depression Rating Scale.

Safety Considerations
  • Low incidence of weight gain and sexual dysfunction, and no safety signal identified for tardive dyskinesia2
    • Weight gain and sexual dysfunction were not observed in SPRAVATO®
      trials at a rate greater than ≥2% and placebo2

Adverse Events

SPRAVATO® monotherapy adverse events chartSPRAVATO® monotherapy adverse events chart

There were no new safety signals that emerged.7

  • Of the treatment-emergent adverse events (TEAE) that occurred on the day of dosing in the monotherapy study, the majority (~90%) resolved on the same day8
    • The majority of dissociation (99.6%), blood pressure increase (100%), and sedation (93.5%) TEAEs occurred and resolved on the same day8
  • 2.7% of patients taking SPRAVATO® in the monotherapy study discontinued treatment due to adverse events8

AR = adverse reaction. For additional information, please see full Prescribing Information

Discontinuation Rates

SPRAVATO® monotherapy 2.7% discontinuation rates infographicSPRAVATO® monotherapy 2.7% discontinuation rates infographic

Other Adverse Reactions ≥ 2%

SPRAVATO® monotherapy additional adverse reactions infographicSPRAVATO® monotherapy additional adverse reactions infographic

SPRAVATO® is administered at certified treatment centers.

Find a Center

References:

  1. 1.Data on File. Janssen Pharmaceuticals, Inc.

  2. 2.SPRAVATO® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.

  3. 3.Janik A, Qiu X, Lane R, et al. Efficacy and safety of esketamine nasal spray as monotherapy in adults with treatment-resistant depression: a randomized, double-blind, placebo-controlled study. Poster presented at: American College of Neuropsychopharmacology (ACNP) Annual Congress; December 8-11, 2024; Phoenix, AZ.

  4. 4. Janik A, Qiu X, Lane R, et al. Efficacy and safety of esketamine nasal spray as monotherapy in adults with treatment-resistant depression: a randomized, double-blind, placebo-controlled study. Poster presented at: European College of Neuropsychopharmacology (ECNP) Annual Congress; September 21-24, 2024; Milan, Italy.

  5. 5. Janik A, Qiu X, Lane R, et al. Efficacy and safety of esketamine nasal spray as monotherapy in adults with treatment-resistant depression: a randomized, double-blind, placebo-controlled study. Poster presented at: American Society of Clinical Psychopharmacology (ASCP) Annual Meeting; May 28-31, 2024; Miami, FL.

  6. 6.Zaki N, Fu DJ, Daly E, et al. Long-Term safety of esketamine nasal spray in adults with treatment-resistant depression: a subgroup analysis of the ongoing SUSTAIN-3 study. Poster presented at: Neuroscience Education Institute (NEI) Congress; November 4-7, 2021; Colorado Springs, CO.

  7. 7.Fu DJ, Lopena O, Quach P, Zaki N, Sun L. A post hoc analysis of patients who received esketamine nasal spray monotherapy in an open-label safety extension study (SUSTAIN-3). Poster presented at: American Society of Clinical Psychopharmacology (ASCP) Annual Meeting; May 31-June 3, 2022; Scottsdale, AZ.

  8. 8.Data on File. SD-217566. Janssen Pharmaceuticals, Inc.

Reduction in the burden of depressive symptoms

SPRAVATO® + oral AD is proven to provide rapid and superior improvement in depressive symptoms at Day 281

TRANSFORM-2 (Short-Term)

SPRAVATO® + oral AD time course of treatment response chartSPRAVATO® + oral AD time course of treatment response 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, and the difference between these 2 groups generally remained the same

AD=antidepressant.

LS=least squares.

MADRS=Montgomery-Åsberg Depression Rating Scale.

Click here to see short-term safety data

Results from a post-hoc analysis of TRANSFORM-2 (Study 1)


Numerical improvement seen across all 10 MADRS items at Day 28

SPRAVATO® TRANSFORM-2 post-hoc analysis chartSPRAVATO® TRANSFORM-2 post-hoc analysis chart

SPRAVATO® is indicated for adults with TRD. This study was not powered to draw conclusions for individual items of MADRS and statistical significance has not been established.

MADRS=Montgomery-Åsberg Depression Rating Scale; TRD=treatment-resistant depression.

TRD Study 1
(Short-Term) study design2,3

Evaluated in a randomized, placebo-controlled, double-blind, short-term (4-week) study in adults with TRD; all patients in the trial received a new oral AD. Primary endpoint was change from baseline in the MADRS total score at 4 weeks.2,3

Demonstrated superior improvement in depression symptoms at Week 4 for adults with TRD2,3

TRD Study 1 short-term study design infographicTRD Study 1 short-term study design overview of SPRAVATO® + new oral AD and placebo nasal spray + new oral AD

Other Secondary Descriptive Endpoints

  • Response at Week 4
  • Remission at Week 4

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

SNRI=serotonin and norepinephrine reuptake inhibitor.

SSRI=selective serotonin reuptake inhibitor.

Key secondary efficacy results3,4
  • 7.9% of patients receiving SPRAVATO® + oral AD achieved response by Day 2 and maintained response by Day 28 vs 4.6% with placebo + oral AD
    • The difference was not statistically significant
  • Mean total SDS score change with SPRAVATO® + oral AD was -13.6 vs -9.4 with placebo + oral AD by Day 28
  • Mean total PHQ-9 score change with SPRAVATO® + oral AD was -13.0 vs -10.2 with placebo + oral AD by Day 28

*Response was defined as ≥50% improvement in MADRS total score by Day 2 that continued through to the end of the double-blind treatment phase, with 1 excursion allowed.

Given the lack of statistical significance on the first secondary endpoint, analyses of the other 2 key secondary endpoints could not be formally evaluated.†

†The 3 key secondary endpoints were analyzed sequentially and were considered significant at the 2-sided, 0.05 level only if the individual and previous endpoints in the hierarchy, including the primary endpoint, were significant.

AD=antidepressant.

MADRS=Montgomery-Åsberg Depression Rating Scale.

PHQ-9=Patient Health Questionnaire-9 (used specifically for depression).

SDS=Sheehan Disability Scale.

Secondary descriptive endpoints:
  • At Week 4, 52.5% of patients receiving SPRAVATO® + oral AD achieved remission vs 31.0% with placebo + oral AD

TRD Study 1 (Short-Term)

SPRAVATO® comparison of secondary descriptive endpoints between response rates at week 4 versus remission rates at week 4 graphSPRAVATO® comparison of secondary descriptive endpoints between response rates at week 4 versus remission rates at week 4 graph
  • 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

Short-term studies:
TRD safety and tolerability of SPRAVATO®

SPRAVATO® plus oral antidepressant offers your patients a consistent safety profile with a minimal risk for sexual dysfunction compared to placebo + oral antidepressant2,5

  • Sexual dysfunction was not observed in SPRAVATO® trials at a rate greater than 2%

TRD=treatment-resistant depression in adults (for patients with MDD who have had an inadequate response to 2 or more oral ADs).

Adverse events chart of SPRAVATO® + oral AD versus placebo + oral ADAdverse events chart of SPRAVATO® + oral AD versus placebo + oral AD

Most TEAEs (93.7%) occurred and resolved on the same day of dosing6

In a 4-week study, the majority of dissociation (98.3%), blood pressure increase (86.4%), and sedation (83.3%) occurred and resolved on the same day of dosing6

*The following terms were combined:

Dissociation includes: delusional perception; depersonalization/derealization disorder; derealization; diplopia; dissociation; dysesthesia; feeling cold; feeling hot; feeling of body temperature change; hallucination; hallucination, auditory; hallucination, visual; hyperacusis; illusion; ocular discomfort; oral dysesthesia; paresthesia; paresthesia oral; pharyngeal paresthesia; photophobia; time perception altered; tinnitus; vision blurred; visual impairment

Dizziness includes: dizziness; dizziness exertional; dizziness postural; procedural dizziness

Sedation includes: altered state of consciousness; hypersomnia; sedation; somnolence

Vertigo includes: vertigo; vertigo positional

Hypoesthesia includes: hypoesthesia; hypoesthesia oral, hypoesthesia teeth, pharyngeal hypoesthesia

Anxiety includes: agitation; anticipatory anxiety; anxiety; fear; feeling jittery; irritability; nervousness; panic attack;tension

Lethargy includes: fatigue; lethargy

Blood pressure increased includes: blood pressure diastolic increased; blood pressure increased; blood pressure systolic increased; hypertension

Headache includes: headache; sinus headache

Dysgeusia includes: dysgeusia; hypogeusia

Nasal discomfort includes: nasal crusting; nasal discomfort; nasal dryness; nasal pruritus

Dysarthria includes: dysarthria; slow speech; speech disorder

Tachycardia includes: extrasystoles; heart rate increased; tachycardia

AD=antidepressant.

TEAEs=treatment-emergent adverse effects.

Click here to see long-term efficacy data
You can have the confidence that SPRAVATO® demonstrated low discontinuation rates:
4.6% of patients taking SPRAVATO® discontinued treatment due to adverse events infographic

*Two short-term TRD studies in adults <65 years.

SPRAVATO® is administered at REMS certified treatment centers

Find a Center

Safety Considerations2

Click to expand each SPRAVATO® safety consideration below

Contraindications
Suicidal Thoughts and Behaviors in Young Adults
Sedation
Blood Pressure
Dissociation
Cognitive Impairment
Respiratory Depression
Impaired Ability to Drive and Operate Heavy Machinery
Abuse and Misuse
Ulcerative or Interstitial Cystitis
REMS
Use in Specific Populations
Drug Interactions

References:

  1. 1.Data on File. Janssen Pharmaceuticals, Inc.

  2. 2.SPRAVATO® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.

  3. 3.Popova V, Daly E, 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. doi:10.1176/appi.ajp.2019.19020172

  4. 4.Popova V, Daly E, 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)(Suppl). https://ajp.psychiatryonline.org/doi/suppl/10.1176/appi.ajp.2019.19020172/suppl_file/appi.ajp.2019.19020172.ds001.pdf

  5. 5. Data on File. Janssen Pharmaceuticals, Inc.

  6. 6. Data on File. Janssen Pharmaceuticals, Inc.

Safety results from the long-term SUSTAIN-3 trial: SPRAVATO® plus an oral antidepressant showed a consistent long-term safety profile over 5 years.2-5

Most TEAEs were mild or moderate and resolved on day of dosing

During the combined Induction and Optimization/Maintenance phases, 967 patients (94.7%) experienced a treatment-emergent adverse event (TEAE)3

IND Phase=56 mg or 84 mg — twice weekly.

OP/M Phase=56 mg or 84 mg — flexibly dosed.*

*Based on CGI-S and tolerability.

SPRAVATO® SUSTAIN-3 TRD long-term study results treatment-emergent adverse events table
  • For SPRAVATO® + oral AD, the majority of TEAEs resolved on day of dosing
    • In a long-term extension study, the majority of dissociation (99.9%), blood pressure increased (96.4%), and sedation (99.5%) TEAEs resolved on day of dosing
  • Safety results from the long-term SUSTAIN-3 trial over 5 years were consistent with the safety and tolerability profile established in the pivotal trials
Additional 5+ year safety results3
  • A total of 184 patients (18.0%) experienced serious TEAEs; serious TEAEs occurring in >5 patients included depression (n=16), suicide attempt (n=15), suicidal ideation (n=9), and COVID-19 (n=7)
  • Six deaths (0.6%) related to TEAEs occurred; investigator assessment determined none were considered to be related to SPRAVATO®
You can have the confidence that SPRAVATO® demonstrated low discontinuation rates:
4-week and 6-year TRD study percentages of patients taking SPRAVATO® who discontinued treatment due to adverse events infographic

*Two short-term TRD studies in adults aged <65 years.

†Median duration of exposure to SPRAVATO® was 46.9 months (range, 0-79).

IND=Induction.

OP/M=Optimization/Maintenance.

SPRAVATO® showed durability over time

TRD 5+ year MADRS Results & PHQ-9 Scores

In a long-term, open-label safety study, MADRS and PHQ-9 scores were consistent throughout analyses of the final data over 5.1 years3

TRD=treatment-resistant depression in adults (for patients with MDD who have had an inadequate response to 2 or more oral ADs).

Mean MADRS Total Scores (Observed Cases) during the induction and optimization/maintenance phases over 5 years graphMean MADRS Total Scores (Observed Cases) during the induction and optimization/maintenance phases over 5 years graph

The proportions of patients in remission were 36.3% at IND endpoints and 49.6% at OP/M.3 Among the patients included in the analysis, 440 (43.1%) entered at IND and 581 (56.9%) entered at OP/M.3

The proportions of patients in remission were 36.3% at IND endpoints and 49.6% at OP/M.3

Among the patients included in the analysis, 440 (43.1%) entered at IND and 581 (56.9%) entered at OP/M.3

6.5-year safety trial was composed of 2 phases: a 4-week IND phase and a variable duration OP/M phase.2

  • Of the 1021 patients studied in this cohort, 50% were treated with SPRAVATO® for at least 46.9 months
    • Patients eligible for this subgroup analysis were 18-64 years of age and received SPRAVATO® 56 mg or 84 mg twice weekly during IND phase and flexible dosing during OP/M phase; all patients should have taken a permitted oral AD for the duration of the study

BL=baseline.

IND=Induction.

OP/M=Optimization/Maintenance.

In a long-term, open-label safety study, MADRS and PHQ-9 scores were consistent throughout analyses of the final data over 5.1 years3

Mean PHQ-9 Total Scores (Observed Cases) during the induction and optimization/maintenance phases over 5 years graphMean PHQ-9 Total Scores (Observed Cases) during the induction and optimization/maintenance phases over 5 years graph

Mean change from baseline in the PHQ-9 total scores (observed cases) showed an improvement over the 4-week IND phase.

This improvement appeared to be maintained with flexibility dosed SPRAVATO® over the OP/M phase.

BL=Baseline; IND=Induction; OP/M=Optimization/Maintenance.

TRD long-term safety extension study3

The following data is drawn from a Phase 3, open-label, long-term safety extension study in adults with treatment-resistant depression (TRD).

Limitations:

  • Results from an open-label, long-term safety study with no comparator group. Efficacy data not assessed for statistical significance
  • This is a subgroup analysis of the study population and there are low n sizes beyond 5.1 years that limit the generalizability of the results
  • Generalizability of study findings may be limited by patients who chose to continue from the parent study and by exclusion of participants with significant comorbidities (psychiatric or medical, or substance dependence)

Study Design2,3

A subgroup analysis was conducted on a cohort of 1021 patients who met criteria consistent with the on-label population. Of the total patients, 440 (43.1%) entered the study at the Induction (IND) phase and 581 (56.9%) entered at the Optimization/Maintenance (OP/M) phase.

  • Patients eligible for this subgroup analysis were 18-64 years of age and received SPRAVATO® 56 mg or 84 mg twice weekly during the IND phase and flexible dosing during the OP/M phase; all patients should have taken a permitted oral AD for the duration of the study
SPRAVATO® TRD long-term safety extension study design infographicSPRAVATO® TRD long-term safety extension study design infographic

Primary objective: Characterize the long-term safety

IND Phase=56 mg or 84 mg – twice weekly.

OP/M Phase=56 mg or 84 mg – flexibly dosed.*

Based on CGI-S and tolerability.

AD=antidepressant.

CGI-S=Clinical Global Impressions-Severity scale.

IND=Induction.

OP/M=Optimization/Maintenance.

SUSTAIN-1 (Long-Term) study design7,8

Evaluated in a long-term, randomized, double-blind, parallel-group, variable duration study in adults who were known remitters and responders. Primary endpoint was time to relapse in patients in stable remission.6,7

Significantly delayed time to relapse in a long-term maintenance trial in adults with TRD with stable remission6,7

SPRAVATO® SUSTAIN-1 (long-term) study design infographicSPRAVATO® SUSTAIN-1 (long-term) study design infographic

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

SPRAVATO® is administered at certified treatment centers.

Find a Center

References:

  1. 1.Data on File. Janssen Pharmaceuticals, Inc.

  2. 2.Zaki N, Fu DJ, Daly E, et al. Long-Term safety of esketamine nasal spray in adults with treatment-resistant depression: a subgroup analysis of the ongoing SUSTAIN-3 study. Poster presented at: Neuroscience Education Institute (NEI) Congress; November 4-7, 2021; Colorado Springs, CO.

  3. 3.Zajecka J, Zaki N, Fu D et al. Long-Term efficacy of esketamine nasal spray dosed in accordance with US prescribing information in adults with treatment-resistant depression: a subgroup analysis of the SUSTAIN-3 study up to 6.5 years. Poster presented at: Psych Congress; September 6-10, 2023; Nashville, TN.

  4. 4. Reif A, Bitter I, Buyze J, et al. Esketamine nasal spray versus quetiapine for treatment-resistant depression. N Engl J Med. 2023;389(14):1298-309. doi:10.1056/NEJMoa2304145

  5. 5.Fu DJ, Lopena O, Quach P, Zaki N, Sun L. A post hoc analysis of patients who received esketamine nasal spray monotherapy in an open-label safety extension study (SUSTAIN-3). Poster presented at: American Society of Clinical Psychopharmacology (ASCP) Annual Meeting; May 31-June 3, 2022; Scottsdale, AZ.

  6. 6.Data on File. Janssen Pharmaceuticals, Inc.

  7. 7.SPRAVATO® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.

  8. 8.Daly E, Trivedi M, Janik A, et al. Efficacy of esketamine nasal spray plus an oral antidepressant treatment for relapse prevention in patients with treatment-resistant depression: a randomized clinical trial. JAMA Psychiatry. 2019; 76(9):893-903.

After initial 16 weeks, patients who stayed on SPRAVATO® for 4 additional months* continued to maintain maintained a clinical benefit2†

SPRAVATO® vs QUE XR Primary Endpoint graphSPRAVATO® vs QUE XR Primary Endpoint graph

*4 months represents the median exposure to SPRAVATO® during maintenance (17.7 weeks and 19.4 weeks in stable remitters and stable responders, respectively).

†As measured by the risk of relapse and the time to relapse in adult patients with treatment-resistant depression who experienced stable remission or response during the initial 16 weeks.

Maintenance-of-effect study

In the long-term maintenance-of-effect trial, patients in stable remission were less likely to relapse* when they continued SPRAVATO® vs those who discontinued and were switched to placebo 2,3

SUSTAIN-1 (Long-Term)

SPRAVATO® SUSTAIN-1 (long-term) maintenance-of-effect study graphSPRAVATO® SUSTAIN-1 (long-term) maintenance-of-effect study graph
  • 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.

MADRS=Montgomery-Åsberg Depression Rating Scale.

References:

1.Data on File. Janssen Pharmaceuticals, Inc.

2.Daly E, Trivedi M, Janik A, et al. Efficacy of esketamine nasal spray plus an oral antidepressant treatment for relapse prevention in patients with treatment-resistant depression: a randomized clinical trial. JAMA Psychiatry. 2019; 76(9):893-903.

3.SPRAVATO® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.

References:

1.Data on File. Janssen Pharmaceuticals, Inc.

2.Daly E, Trivedi M, Janik A, et al. Efficacy of esketamine nasal spray plus an oral antidepressant treatment for relapse prevention in patients with treatment-resistant depression: a randomized clinical trial. JAMA Psychiatry. 2019; 76(9):893-903.

3.SPRAVATO® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.

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