NDAINTRAVENOUS, INTRAVENOUSSOLUTION, SOLUTIONPriority Review
Approved
Jan 2011
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
Priority Review
NITHIODOTE (sodium nitrite and sodium thiosulfate) by Hope Pharmaceuticals is poison. Approved for acute cyanide poisoning, life-threatening. First approved in 2011.
Drug data last refreshed 6h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NITHIODOTE is a fixed-dose combination of sodium nitrite and sodium thiosulfate administered intravenously for acute cyanide poisoning. Sodium nitrite converts hemoglobin to methemoglobin, which binds cyanide preferentially and displaces it from cytochrome oxidase; sodium thiosulfate enhances endogenous enzymatic detoxification via rhodanese-catalyzed conversion to thiocyanate. This synergistic mechanism restores aerobic cellular respiration and prevents death from rapid cyanide-induced cytotoxicity.
Peak5.5 years to LOE
Peak-stage specialty/emergency product with limited market size; small, stable team focus on hospital formulary and poison control center relationships.
Mechanism of Action
poison. In the absence of rapid and adequate treatment, exposure to a high dose of cyanide can result in death within minutes due to the inhibition of cytochrome oxidase resulting in arrest of cellular respiration. Specifically, cyanide binds rapidly with cytochrome a3, a component of the…
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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.