Efficacy SMDD

Your adult patients with depressive symptoms of MDSI may find the efficacy they've been seeking

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TRD
MDSI

Rapid reduction of depressive symptoms with superior improvement at 24 hours for adults with MDSI1,2

Pooled analysis

Primary Endpoint: demonstrated RAPID reduction of MDD symptoms as measured by the change from baseline MADRS total score at 24 hours

• The benefit of SPRAVATO® was observed, starting at 4 hours

• Between 4 hours and Day 25, both the SPRAVATO® and placebo groups continued to improve; the difference between the groups generally remained but did not appear to increase over time through Day 25

LS=least-squares.

MADRS=Montgomery-Åsberg Depression Rating Scale.

SOC=comprehensive standard of care.

Study 3 Design1

Study 3 was a Phase 3, short-term (4-week), randomized, double-blind, multicenter, placebo-controlled study in adult patients with moderate to severe MDD (MADRS total score >28) who had active suicidal ideation with intent.

Pooled analysis

Comprehensive SOC treatment included an initial inpatient psychiatric hospitalization and a newly initiated or optimized oral antidepressant (AD) (AD monotherapy or AD plus augmentation therapy) as determined by the investigator. After completion of the 4-week treatment period with SPRAVATO®/placebo, study follow-up continued through Day 90.

Primary Endpoint

  • Reduction of severity of depressive symptoms of MDD as measured by the change from baseline MADRS total score at 24 hours after first dose (Day 2)

Dosing

  • Patients received treatment with SPRAVATO® 84 mg or placebo nasal spray twice weekly for 4 weeks
  • After the first dose, a one-time dose reduction to SPRAVATO® 56 mg was allowed for patients unable to tolerate the 84-mg dose

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

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

2. 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.