Last reviewed 2026-04-20 · How we verify

OXN PR tablet

At a glance

Approved indications

No approved indications tracked.

Common side effects

• Sleepiness
• headache
• Difficult defecation
• Hypertriglyceridemia
• dizziness
• upper respiratory tract infection
• Elevated aminotransferase
• Chest discomfort
• constipation
• abdominal distension
• Dry mouth
• vomit

Key clinical trials

• OXN PR Tablet 5/2.5 mg and20/10 mg PK Study in Chinese Moderate to Severe Chronic Non-malignant Patients (PHASE1)
• OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS) (PHASE2)
• A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy (PHASE3)
• Oxycodone/Naloxone Prolonged Release (OXN PR) Compared to Placebo to Demonstrate Improvement in Symptoms of Restless Legs Syndrome (RLS) in Subjects With Moderate to Severe Idiopathic RLS With Daytime Symptoms (PHASE3)
• OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects (PHASE3)
• To Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Between OXN PR Higher Dose & Lower Dose Tablet Strengths in Subjects With Non-cancer or Cancer Pain (PHASE2, PHASE3)
• A Study to Explore the Influence of Two Opioid Pain Medications on Bacterial Composition in the Gut and Other Gastrointestinal Aspects (PHASE2)
• Efficacy of Oxycodone/Naloxone(OXN), Versus Oxycodone (OXY), for the Reduction of Intensity of Opioid-induced Constipation in Pain Patients (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• OXN PR tablet CI brief — competitive landscape report
• OXN PR tablet updates RSS · CI watch RSS
• Mundipharma (China) Pharmaceutical Co. Ltd portfolio CI