NDAINTRAMUSCULAR, SUBCUTANEOUSSOLUTIONPriority Review
Approved
Aug 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
4/8 — 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. First approved in 2024.
Drug data last refreshed 21h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZURNAI is a nalmefene hydrochloride autoinjector designed for emergency reversal of opioid overdose and respiratory depression. It is an opioid antagonist with a longer duration of action than naloxone, offering rapid receptor occupancy (>80% of brain opioid receptors within 5 minutes). The drug has no agonist activity and does not produce respiratory depression, psychotomimetic effects, or abuse potential.
Growth13.0 years to LOE
Recently approved product in growth phase; early-stage commercial team building with focus on emergency medicine and opioid crisis response market penetration.
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.