About SPRAVATO® SMDD

What makes 
SPRAVATO® different?

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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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UNMET NEED IN MDSI

Estimated to have MDD

17.6 million adults are estimated to have MDD in the US.5

active suicidal ideation

11.5% of these patients have active suicidal ideation with intent.5

administered oral antidepressant

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

SPRAVATO® clinical program overview

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

BASELINE PATIENT CHARACTERISTICS1

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

 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 40

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

MADRS=Montgomery-Åsberg Depression Rating Scale.

Patients in both arms received comprehensive standard-of-care (SOC) treatment, including an initial inpatient 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. Uher R, et al. Major depressive disorder in DSM-5: implications for clinical practice and research of changes from DSM-IV. Depress Anxiety. 2014;31:459-471.

3. Grunebaum MF, et al. Pilot randomized clinical trial of an SSRI vs bupropion: effects on suicidal behavior, ideation, and mood in major depression. Neuropsychopharmacology. 2012;37:697-706.

4. Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Prefer and Adherence. 2012;6:369-388.

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

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