NDAINJECTIONINJECTABLEPriority Review
Approved
Sep 1979
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
5/8 — Partial
Priority Review
DANTRIUM (dantrolene sodium) by Pfizer is clinical pharmacology: in isolated nerve-muscle preparation, dantrium has been shown to produce relaxation by affecting the contractile response of the muscle at a site beyond the myoneural junction. First approved in 1979.
Drug data last refreshed 6h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Dantrium (dantrolene sodium) is a skeletal muscle relaxant that works by dissociating excitation-contraction coupling at the sarcoplasmic reticulum level, reducing calcium release in muscle cells. It is indicated for malignant hyperthermia (MH) crisis treatment and prophylaxis, a life-threatening pharmacogenetic reaction to certain anesthetic agents. The drug directly addresses abnormal myoplasmic calcium elevation in MH-susceptible patients, restoring cellular calcium equilibrium and preventing or attenuating the cascade of metabolic and physiologic derangement.
$0.01BPart D
LOE ApproachingLow commercial activity with minimal Part D claims (46 in 2023) reflects the niche, high-acuity nature of malignant hyperthermia, limiting team size and commercial expansion opportunities.
Mechanism of Action
CLINICAL PHARMACOLOGY: In isolated nerve-muscle preparation, Dantrium has been shown to produce relaxation by affecting the contractile response of the muscle at a site beyond the myoneural junction. In skeletal muscle, Dantrium dissociates the excitation-contraction coupling, probably by…
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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.