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 5h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NARCAN (naloxone hydrochloride) is an opioid antagonist administered by injection that reverses opioid overdose by blocking µ, κ, and σ opioid receptors in the CNS. It rapidly reverses respiratory depression, sedation, hypotension, and overdose effects within 2 minutes of IV administration. The drug is indicated for opioid overdose and fentanyl overdose reversal.
LOE Approaching
NARCAN faces moderate competitive pressure (30/100) from multiple naloxone formulations and newer alternatives; teams should prepare for market maturation and possible role consolidation.
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.