NDAINJECTIONINJECTABLE
Approved
Apr 1959
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
3/8 — Basic
OPANA (oxymorphone hydrochloride) by Ascentage Pharma is oxymorphone, a pure opioid agonist, is relatively selective for the mu receptor, although it can interact with other opioid receptors at higher doses. First approved in 1959.
Drug data last refreshed 17h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OPANA (oxymorphone hydrochloride) is a pure mu-opioid receptor agonist approved in 1959 for the treatment of pain via injection. It works by binding to opioid receptors in the central nervous system to modulate pain perception, with a mechanism similar to other opioid analgesics but with relatively selective mu-receptor activity.
LOE Approaching
As an LOE-approaching injectable opioid with 30% competitive pressure, OPANA teams are likely consolidating and transitioning to support generic transition or portfolio rotation.
Mechanism of Action
Oxymorphone, a pure opioid agonist, is relatively selective for the mu receptor, although it can interact with other opioid receptors at higher doses. The precise mechanism of analgesia, the principal therapeutic action of oxymorphone, is unknown. Specific CNS opiate receptors and endogenous…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
COPANA - A09 PCSK 9 Substudy: Impact of Protease Inhibitors on PCSK9 Levels in Naive HIV-Infected Patients
Started Mar 2016
193 enrolled
HIV SeropositivityDyslipidemiasPCSK9
Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fasted Conditions
Started Nov 2007
50 enrolled
Pain
Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fed Conditions
Started Nov 2007
32 enrolled
Pain
Worked on OPANA at Ascentage Pharma? Share your interview experience or compensation data (+7 days Pro)
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.