NDAINJECTIONINJECTABLE
Approved
Mar 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
NALBUPHINE HYDROCHLORIDE (nalbuphine hydrochloride) by AbbVie is clinical pharmacology mechanism of action nalbuphine is an agonist at kappa opioid receptors and an antagonist at mu opioid receptors. First approved in 1993.
Drug data last refreshed 1h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Nalbuphine hydrochloride is a mixed opioid agonist-antagonist injectable analgesic that acts as a kappa receptor agonist and mu receptor antagonist. It provides potent analgesia equivalent to morphine at doses up to 30 mg with a ceiling effect on respiratory depression. It is indicated for pain management and respiratory insufficiency, with a unique safety profile that may reverse opioid-induced respiratory depression from mu agonists.
LOE Approaching
Product is in late-stage commercial lifecycle (LOE approaching), suggesting smaller brand team focus and shift toward lifecycle management rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Mechanism of Action Nalbuphine is an agonist at kappa opioid receptors and an antagonist at mu opioid receptors. Pharmacodynamics Nalbuphine hydrochloride injection is a potent analgesic. Its analgesic potency is essentially equivalent to that of morphine on a milligram basis…
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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.