NDANASALSPRAYPriority Review
Approved
Mar 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 43m ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SPRAVATO is an FDA-approved nasal spray formulation of esketamine hydrochloride, an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for treatment-resistant depression (TRD) and depressive symptoms in patients with major depressive disorder (MDD) who are at imminent risk for suicide. It is administered in a healthcare setting under medical supervision and represents the first and only FDA-approved rapid-acting antidepressant for acute suicidal ideation or behavior.
$80MPart D
Peak13.5 years to LOEStrong commercial peak with $80M in Part D spending and sustained claim volume; commercial and product development teams are actively managing market penetration and label expansion.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Reward Emotion Learning and Ketamine Study
Started Aug 2021
70 enrolled
DepressionMajor Depressive DisorderTreatment Resistant Depression
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.