NDAINJECTIONINJECTABLEPriority Review
Approved
Apr 1971
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
Priority Review
NARCAN (naloxone hydrochloride) by Bristol Myers Squibb is clinical pharmacology complete or partial reversal of opioid depression naloxone hydrochloride prevents or reverses the effects of opioids including respiratory depression, sedation, and hypotension. First approved in 1971.
Drug data last refreshed 48m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NARCAN (naloxone hydrochloride) is a pure opioid antagonist administered via injection that rapidly reverses opioid-induced respiratory depression, sedation, and hypotension. It competitively binds to µ, κ, and σ opioid receptors in the CNS, with highest affinity for the µ receptor, restoring normal respiratory function within minutes. The drug is also used adjunctively in septic shock, though its survival benefit remains unproven.
LOE Approaching
As LOE approaches, the NARCAN team will prioritize cost management and market defense against generic entrants rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Complete or Partial Reversal of Opioid Depression Naloxone hydrochloride prevents or reverses the effects of opioids including respiratory depression, sedation, and hypotension. Also, naloxone hydrochloride can reverse the psychotomimetic and dysphoric effects of…
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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.