About SPRAVATO® SMDD
What makes
SPRAVATO® different?
Actor portrayal.
The first and only NMDA receptor antagonist approved for 2 subtypes of MDD in adult patients1
SPRAVATO® hypothesized mechanism of action (MOA)
UNMET NEED IN MDSI
17.6 million adults are estimated to have MDD in the US.5
11.5% of these patients have active suicidal ideation with intent.5
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
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
Patients had a mean MADRS score of 40
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 psychiatric hospitalization and a newly initiated or optimized oral antidepressant (AD) therapy (AD monotherapy or AD plus augmentation) as determined by the investigator
Meet 3 adult patients with MDD in need of timely attention who may be appropriate for SPRAVATO® therapy*
SPRAVATO® therapy for appropriate adult patients with MDD in need of timely attention should only begin after a full evaluation and discussion with a healthcare provider.
*Not actual patients.
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.
Actor portrayal.
Meet Sherin, age 32
- Diagnosed with major depressive disorder (MDD) 9 years ago
- Has recently experienced worsening of her depressive symptoms
Presentation and psychiatric history
MDSI
Sherin has experienced some improvement in her symptoms in the past, but that improvement has never lasted longer than a few months. Recently, Sherin has been quieter than usual during her appointments.
During her last visit, she revealed new, frequent thoughts of harming herself, but did not yet have a plan.
Has tried a variety of treatments in the past, including selective serotonin reuptake inhibitors (SSRls), serotonin and norepinephrine reuptake inhibitors (SNRls), serotonin modulators, antipsychotic augmentation, and repetitive transcranial magnetic stimulation (rTMS).
Has declined to receive electroconvulsive therapy (ECT) due to a family member's past experience with this therapy.
Other history
MDSI
No other comorbidities.
Has lived with partner for 6 years; involved in community theater; no history of substance abuse; nonsmoker.
Has employer-sponsored health insurance.
See how SPRAVATO® may be the right treatment for patients like Sherin.
Actor portrayal.
Meet Doug, age 28
- Reported symptoms of depressed mood, anhedonia, hopelessness, fatigue, and difficulty concentrating for the past 6 months
- At this time also reporting suicidal ideation
Presentation and psychiatric history
MDSI
No prior psychiatric diagnoses or treatment.
Primary care physician just referred to psychiatrist due to newly reported depressive symptoms.
At this time also reporting suicidal ideation but no prior suicide attempt.
Other history
MDSI
Has no past medical history other than electrolyte imbalance attributed to rapid weight loss from depression-related loss of appetite. Electrolyte imbalance managed as outpatient.
Is a full-time graduate student and has no children; wife works full-time. No history of substance abuse; no other medical illnesses; nonsmoker.
Has employer-sponsored health insurance through his wife.
Patients like Doug may benefit from SPRAVATO®.
Actor portrayal.
Meet Myra, age 38
- Diagnosed with major depressive disorder 2 years ago
- Under care of a private practice psychiatrist
Presentation and psychiatric history
MDSI
Normally open with her feelings and talkative, Myra was in a pensive mood at her last psychiatrist visit. She revealed she fears she will lose her job and that her husband is threatening to leave her because she has such difficulty getting out of bed in the mornings due to her depressive symptoms.
No prior hospitalizations or suicide attempts.
Has tried a selective serotonin reuptake inhibitor (SSRI), a norepinephrine and dopamine reuptake inhibitor (NDRI), and a tetracyclic antidepressant.
Recently obtained a large quantity of medication and is considering overdosing intentionally.
Psychiatrist arranged for transport to the local ER, where she was admitted to the hospital.
Other history
MDSI
Diagnosed with fibromyalgia 3 years ago.
Is a part-time administrative assistant; married; 2 children; usually actively involved in church and with family. No history of substance use; nonsmoker.
Has employer-sponsored health insurance.
Patients like Myra require the timely attention that SPRAVATO® may offer.