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Hydromorphone HCl OROS
Hydromorphone HCl OROS is an opioid agonist that binds to mu-opioid receptors in the central nervous system to produce analgesia and is formulated as an extended-release osmotic system for sustained pain relief.
Hydromorphone HCl OROS is an opioid agonist that binds to mu-opioid receptors in the central nervous system to produce analgesia and is formulated as an extended-release osmotic system for sustained pain relief. Used for Moderate to severe chronic pain requiring around-the-clock opioid therapy.
At a glance
| Generic name | Hydromorphone HCl OROS |
|---|---|
| Sponsor | Janssen Korea, Ltd., Korea |
| Drug class | Opioid agonist |
| Target | Mu-opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | FDA-approved |
Mechanism of action
Hydromorphone is a semi-synthetic opioid that activates mu-opioid receptors throughout the brain and spinal cord, inhibiting pain signal transmission and producing analgesia. The OROS (osmotic release oral system) formulation uses osmotic pressure to deliver the drug at a controlled rate over 24 hours, providing consistent pain management with reduced dosing frequency compared to immediate-release formulations.
Approved indications
- Moderate to severe chronic pain requiring around-the-clock opioid therapy
Common side effects
- Constipation
- Nausea
- Dizziness
- Drowsiness
- Vomiting
- Respiratory depression
Key clinical trials
- A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic Osteoarthritis (OA) Pain (PHASE3)
- Study to Test the Effectiveness of Controlled-Release OROS® Hydromorphone HCl Compared to Placebo in Patients With Chronic Low Back Pain (PHASE3)
- A Repeated Dose Study of the Metabolism and Action Evaluation of OROS Hydromorphone HCI (Slow Release) Tablets in Patients With Chronic Pain (PHASE1)
- A Pharmacokinetic and Safety Study of Osmotic Release Oral System (OROS) Hydromorphone in Non-Opioid Tolerant Chinese Participants With Cancer (PHASE1)
- A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain. (PHASE3)
- Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee (PHASE3)
- Clinical Usefulness and Quality of Life of OROS Hydromorphone in Patients Who Have Not Been Treated With a Strong Opioid
- An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Hydromorphone HCl OROS CI brief — competitive landscape report
- Hydromorphone HCl OROS updates RSS · CI watch RSS
- Janssen Korea, Ltd., Korea portfolio CI