Your adult patients with depressive symptoms of MDSI may find the efficacy they've been seeking
Rapid reduction of depressive symptoms with superior improvement at 24 hours for adults with MDSI1,2
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
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.
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.
- 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)
- 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
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.