Overview of Opana ER (Oxymorphone ER)
Opana ER (oxymorphone hydrochloride extended-release) is a Schedule II semi-synthetic opioid analgesic formulated for around-the-clock management of moderate-to-severe chronic pain. Available in multiple strengths—including 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg—these octagonal tablets use TIMERx technology for controlled release over 12 hours.
Pharmacokinetics & Dosing Strategy
Bioavailability: ~10% orally; food increases Cₘₐₓ by ~50%, so tablets should be taken 1 hour before or 2 hours after meals
Onset & Duration: Extended-release provides peak plasma levels in ~2.5–4 hours, lasting approximately 12 hours per dose
Initial dosing: Opioid-naïve adults typically start with 5 mg every 12 hours, adjusted based on prior opioid use (e.g., 50% conversion from other opioids)
Titration: Increase in 5–10 mg increments every 3–7 days to balance efficacy and safety
⚠️ Safety Profile & Clinical Considerations
Potency: Approximately three times stronger than oral morphine and twice that of oxycodone
Risks include:
Respiratory depression, hypotension, CNS sedation (especially with alcohol or sedatives)
Constipation, ileus, and cholestatic effects—requires proactive bowel management .
Addiction and misuse—high dependency potential demands secure storage and adherence to prescription .
Special populations:
Avoid in severe hepatic or renal impairment; elderly require cautious dosing due to slower clearance and higher plasma levels .
Taper gradually—do not stop abruptly—to prevent withdrawal
✅ Why Opana ER Matters in Clinical Research
Innovative formulation: Controlled-release design balanced consistent pain relief with efforts to reduce abuse—though intravenous misuse prompted FDA withdrawal in 2017
Pharmacologic potency: Strong mu‑opioid agonist profile, suitable for severe, chronic pain management.
Regulatory and public health lessons: Illustrates challenges of balancing opioid innovation, safety, and misuse within post-marketing surveillance contexts.
Summary Table
| Feature | Description |
| Generic Name | Oxymorphone hydrochloride ER |
| Form | 5–40 mg extended-release tablets, taken twice daily |
| Therapeutic use | Long-term management of chronic moderate-to-severe pain |
| Pharmacokinetics | 10% oral bioavailability, 12 hr duration, Tmax ~2–4 hr |
| Clinical cautions | High dependency risk, respiratory/CNS effects, special dosing for elderly/organ impairment |
| Market status | Brand discontinued in 2017; generics still available |
FAQS
❓ Is Opana ER still available?
Brand: No. Opana ER (all strengths: 5–40 mg) was discontinued in 2017 after the FDA requested withdrawal due to serious abuse issues
Generic: Yes. Several FDA-approved oxymorphone ER generics continue to be available in the same strengths
💊 What is Opana ER used for?
It was indicated for around-the-clock management of moderate-to-severe chronic pain in patients who require a consistent opioid effect, not for acute or occasional use
⏱ How long does Opana ER last?
The extended-release formulation provided up to 12 hours of pain control per dose
🏷️ What is the generic name of Opana ER?
The generic name is oxymorphone hydrochloride extended-release
⚖️ What were the dosages available?
Brand Opana ER came in ER tablets of 5, 7.5, 10, 15, 20, 30, and 40 mg
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