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 1h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DARVON (propoxyphene hydrochloride) is a centrally acting oral opioid analgesic approved in 1957 for pain management. It works by inhibiting sodium and potassium channels in addition to its opiate receptor activity, with a major metabolite (norpropoxyphene) that accumulates with repeated dosing and has a significantly longer half-life (30-36 hours vs. 6-12 hours for the parent drug).
LOE Approaching
Product is in late-stage lifecycle with limited commercial expansion opportunities; commercial teams should focus on retention and transition planning rather than growth initiatives.
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.