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OROS hydromorphone HCl
OROS hydromorphone HCl is a Opioid agonist Small molecule drug developed by Janssen-Cilag International NV. It is currently FDA-approved for Moderate to severe chronic pain requiring continuous opioid therapy.
OROS hydromorphone HCl is an extended-release opioid agonist that binds to mu-opioid receptors in the central nervous system to provide sustained pain relief.
OROS hydromorphone HCl is an extended-release opioid agonist that binds to mu-opioid receptors in the central nervous system to provide sustained pain relief. Used for Moderate to severe chronic pain requiring continuous opioid therapy.
At a glance
| Generic name | OROS hydromorphone HCl |
|---|---|
| Sponsor | Janssen-Cilag International NV |
| 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, inhibiting pain signal transmission and modulating pain perception. The OROS (osmotic release oral system) technology provides controlled, extended-release delivery over 24 hours, maintaining steady-state plasma concentrations and reducing dosing frequency compared to immediate-release formulations.
Approved indications
- Moderate to severe chronic pain requiring continuous opioid therapy
Common side effects
- Constipation
- Nausea
- Dizziness
- Somnolence
- Vomiting
- Headache
- Pruritus
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:
- OROS hydromorphone HCl CI brief — competitive landscape report
- OROS hydromorphone HCl updates RSS · CI watch RSS
- Janssen-Cilag International NV portfolio CI
Frequently asked questions about OROS hydromorphone HCl
What is OROS hydromorphone HCl?
How does OROS hydromorphone HCl work?
What is OROS hydromorphone HCl used for?
Who makes OROS hydromorphone HCl?
What drug class is OROS hydromorphone HCl in?
What development phase is OROS hydromorphone HCl in?
What are the side effects of OROS hydromorphone HCl?
What does OROS hydromorphone HCl target?
Related
- Drug class: All Opioid agonist drugs
- Target: All drugs targeting Mu-opioid receptor
- Manufacturer: Janssen-Cilag International NV — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Moderate to severe chronic pain requiring continuous opioid therapy
- Compare: OROS hydromorphone HCl vs similar drugs
- Pricing: OROS hydromorphone HCl cost, discount & access