About SPRAVATO® SMDD

What makes SPRAVATO® (esketamine) different?

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SPRAVATO® (esketamine) is the first and only NMDA receptor antagonist approved for 2 subtypes of MDD in adult patients1

SPRAVATO® hypothesized mechanism of action (MOA)

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TRD=treatment-resistant depression in adults.

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

AE=adverse event.

TEAE=treatment-emergent adverse effect.

UNMET NEED IN MDSI

Estimated to have MDD

17.6 million adults are estimated to have MDD in the US.2

active suicidal ideation

11.5% of these patients have active suicidal ideation with intent.2

administered oral antidepressant

These patients need timely treatment, but a newly administered oral antidepressant may take 4 to 6 weeks to reach full effect.3

Depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior (MDSI)2

Representative patient journey: symptom severity curve for adults with major depressive disorder with acute suicidal ideation or behavior (MDSI)2,4*

Representative patient journey

*While many patients may not follow this linear curve exactly, this is a simplified example of a potential journey for a patient with MDSI after a diagnosis of MDD. It is an adaptation from: Substance Abuse and Mental Health Services Administration. (2019, August 20). Suicide Risk for People with SMI. U.S. Department of Health and Human Services.

  • For patients with MDD, as depressive symptoms increase in severity, patients may quickly progress to acute suicidal ideation or behavior4
  • These patients may be treated in an outpatient setting if clinically appropriate as an alternative to inpatient care. Patients may be treatment naïve or already receiving treatment for MDD
  • SPRAVATO® (esketamine) CIII Nasal Spray is indicated, in conjunction with an oral antidepressant, for the treatment of:
    • Treatment-resistant depression (TRD) in adults.
    • Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.

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 S SPRAVATO®
  • SPRAVATO® is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO® as an anesthetic agent have not been established.

SPRAVATO® clinical program overview

Studied in 449 adult patients with moderate to severe MDD who had active suicidal ideation with intent, across all studies1

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Patients included in MDSI trials had active suicidal ideation or behavior that was characterized by the following3:

  • Thinking (even momentarily) about harming or hurting or injuring oneself
  • Having awareness that they might die as a result of self-harm
  • Intend to act on thoughts of killing oneself
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Patients had a mean MADRS score of 401

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Patients reported active, acute suicidal ideation within 24 hours prior to their first dose of study medication5

MADRS=Montgomery-Åsberg Depression Rating Scale.

COMPARED TO PLACEBO NASAL SPRAY + ORAL AD1

COMPARED TO PLACEBO NASAL SPRAY + ORAL AD
  • Patients in both arms received comprehensive standard-of-care (SOC) treatment, including an initial inpatient psychiatric hospitalization and a newly initiated or optimized oral antidepressant (AD) therapy (AD monotherapy or AD plus augmentation) as determined by the investigator
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Next: Efficacy in TRD and MDSI

Learn more

References:

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

2. Data on file. Janssen Pharmaceuticals, Inc. Titusville, NJ.

3. Practice guideline for the treatment of patients with major depressive disorder (revision). American Psychiatric Association. Am J Psychiatry. 2010:1-152.

4. Sokero TP, et al. Prospective study of risk factors for attempted suicide among patients with DSM-IV major depressive disorder. Br J Psychiatry. 2005;186(4):314-318. doi:10.1192/bjp.186.4.314

5. Fu DJ, 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