NDAORALCAPSULEPriority Review
Approved
Aug 1957
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
Priority Review
DARVON (propoxyphene hydrochloride) by Agepha Pharma is clinical pharmacology pharmacology propoxyphene is a centrally acting opiate analgesic. First approved in 1957.
Drug data last refreshed 8h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DARVON (propoxyphene hydrochloride) is an oral centrally acting opiate analgesic approved in 1957 for pain management. It works by inhibiting sodium channels and voltage-gated potassium (hERG) channels, producing both analgesic and local anesthetic effects. The drug is administered as an oral capsule and is metabolized extensively via CYP3A4 to its active metabolite norpropoxyphene.
LOE Approaching
Product is in late-stage lifecycle with minimal linked job openings, indicating a contracting or consolidating commercial team focused on transition planning.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacology Propoxyphene is a centrally acting opiate analgesic. In vitro studies demonstrated propoxyphene and the metabolite norpropoxyphene inhibit sodium channels (local anesthetic effect) with norpropoxyphene being approximately 2-fold more potent than propoxyphene and…
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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.