NDAINTRAMUSCULAR, SUBCUTANEOUSSOLUTIONPriority Review
Approved
Aug 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
5/8 — Partial
Priority Review
ZURNAI (AUTOINJECTOR) (nalmefene hydrochloride) by Purdue Pharma is clinical pharmacology pharmacodynamics nalmefene hydrochloride injection prevents or reverses the effects of opioids, including respiratory depression, sedation, and hypotension. Approved for opioid overdose. First approved in 2024.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZURNAI is a nalmefene hydrochloride auto-injector that rapidly reverses opioid overdose by blocking opioid receptors in the brain. It prevents or reverses respiratory depression, sedation, and hypotension with a longer duration of action than naloxone. The drug is administered intramuscularly or subcutaneously and reaches therapeutic concentrations within 5–15 minutes.
Growth13.5 years to LOE
Recently approved product in growth phase with strong IP protection through 2039; early-stage commercial infrastructure build-out will drive hiring across field and commercial operations.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacodynamics Nalmefene hydrochloride injection prevents or reverses the effects of opioids, including respiratory depression, sedation, and hypotension. Pharmacodynamic studies have shown that nalmefene hydrochloride injection has a longer duration of action than naloxone…
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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.