NDAORALTABLET, EXTENDED RELEASEPriority Review
Approved
Dec 2011
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
2
Data completeness
4/8 — Partial
Priority Review
OPANA ER (oxymorphone hydrochloride) by Ascentage Pharma is clinical pharmacology oxymorphone is an opioid agonist whose principal therapeutic action is analgesia. First approved in 2011.
Drug data last refreshed 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OPANA ER is an extended-release oral tablet containing oxymorphone hydrochloride, a potent opioid agonist indicated for moderate to severe chronic pain management. It works by binding to opioid receptors in the central and peripheral nervous systems to produce analgesia, with a mechanism of action similar to morphine and other pure opioid agonists. The drug's analgesic ceiling is determined only by adverse effects such as respiratory depression and somnolence, not dose-dependent plateau effects.
Peak3.4 years to LOE
Product is in peak commercial phase with moderate competitive pressure (score: 8/10), but a brand team should anticipate LOE strategy planning within 3-4 years.
Mechanism of Action
CLINICAL PHARMACOLOGY Oxymorphone is an opioid agonist whose principal therapeutic action is analgesia. Other members of the class known as opioid agonists include substances such as morphine, oxycodone, hydromorphone, fentanyl, codeine, hydrocodone, and tramadol. In addition to analgesia, other…
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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.