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OROS Hydromorphone HCI
OROS Hydromorphone HCI is a Opioid analgesic Small molecule drug developed by Alza Corporation, DE, USA. It is currently in Phase 3 development for Moderate to severe chronic pain requiring continuous opioid therapy.
OROS Hydromorphone HCI is an extended-release opioid agonist that binds to mu-opioid receptors in the central nervous system to provide sustained pain relief.
OROS Hydromorphone HCI 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 HCI |
|---|---|
| Sponsor | Alza Corporation, DE, USA |
| Drug class | Opioid analgesic |
| Target | Mu-opioid receptor (μ-OR) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Hydromorphone is a semi-synthetic opioid that activates mu-opioid receptors throughout the brain and spinal cord, reducing the perception and emotional response to pain. 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
Key clinical trials
- A Repeated Dose Study of the Metabolism and Action Evaluation of OROS Hydromorphone HCI (Slow Release) Tablets in Patients With Chronic Pain (PHASE1)
- Clinical Usefulness and Quality of Life of OROS Hydromorphone in Patients Who Have Not Been Treated With a Strong Opioid
- A Study to Evaluate the Effectiveness and Safety of Slow Release Hydromorphone HCL for Treatment of Patients With Osteoarthritis (PHASE3)
- A Repeated-Dose Evaluation of Use of a Pain Relieving Drug and Safety of OROS Hydromorphone HCI in Patients With Chronic Cancer Pain (PHASE3)
- An Open-Label Evaluation of the Independent Effects of Coadministration of a High-Fat Meal and Naltrexone Blockade on the Pharmacokinetic Profile of Dilaudid OROS (Hydromorphone HCI) 16mg (PHASE1)
- Safety and Tolerability of Long-term Administration of OROS Hydromorphone HCI (Slow Release) in Cancer Pain (PHASE3)
- An Effectiveness, Safety and Quality of Life Measures With Hydromorphone HCL, Dilaudid CR (Controlled Release) (PHASE3)
- A Study on Efficacy (Effectiveness), Safety, and Impact on Quality of Life Measures of Dilaudid CR (Controlled Release);, Hydromorphone HCl in Patients With Chronic Low Back Pain (PHASE2)
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 HCI CI brief — competitive landscape report
- OROS Hydromorphone HCI updates RSS · CI watch RSS
- Alza Corporation, DE, USA portfolio CI
Frequently asked questions about OROS Hydromorphone HCI
What is OROS Hydromorphone HCI?
How does OROS Hydromorphone HCI work?
What is OROS Hydromorphone HCI used for?
Who makes OROS Hydromorphone HCI?
What drug class is OROS Hydromorphone HCI in?
What development phase is OROS Hydromorphone HCI in?
What are the side effects of OROS Hydromorphone HCI?
What does OROS Hydromorphone HCI target?
Related
- Drug class: All Opioid analgesic drugs
- Target: All drugs targeting Mu-opioid receptor (μ-OR)
- Manufacturer: Alza Corporation, DE, USA — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Moderate to severe chronic pain requiring continuous opioid therapy
- Compare: OROS Hydromorphone HCI vs similar drugs
- Pricing: OROS Hydromorphone HCI cost, discount & access