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OROS hydromorphone HCL ; Morphine sulfate
OROS hydromorphone HCL ; Morphine sulfate 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 HCl is an extended-release opioid agonist that binds to mu opioid receptors in the central nervous system to provide prolonged pain relief.
OROS hydromorphone HCl is an extended-release opioid agonist that binds to mu opioid receptors in the central nervous system to provide prolonged pain relief. Used for Moderate to severe chronic pain requiring continuous opioid therapy.
At a glance
| Generic name | OROS hydromorphone HCL ; Morphine sulfate |
|---|---|
| Sponsor | Alza Corporation, DE, USA |
| Drug class | Opioid analgesic |
| Target | Mu opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
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. Morphine sulfate is also included as a reference comparator, being a natural opioid alkaloid with similar mu receptor agonist activity.
Approved indications
- Moderate to severe chronic pain requiring continuous opioid therapy
Common side effects
- Constipation
- Nausea
- Dizziness
- Somnolence
- Vomiting
- Headache
Key clinical trials
- 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)
- An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain (PHASE3)
- An Efficacy and Safety Study of Hydromorphone Oral Osmotic System (OROS) in Korean Participants With Cancer Pain (PHASE4)
- Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain (PHASE4)
- A Study to Compare Safety and Efficacy of Osmotic Release Oral Syytem (OROS) Hydromorphone Hydrochloride (HCl) With Morphine Sustain Release (SR) in Participants With Cancer Pain (PHASE3)
- Pharmacokinetic Profile of OROS Hydromorphone in Healthy Taiwanese Participants With Different Genotypes for the UGT2B7 Gene (PHASE1)
- A Study of OROS Hydromorphone HCL vs Morphine in Cancer 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.
| 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 ; Morphine sulfate CI brief — competitive landscape report
- OROS hydromorphone HCL ; Morphine sulfate updates RSS · CI watch RSS
- Alza Corporation, DE, USA portfolio CI
Frequently asked questions about OROS hydromorphone HCL ; Morphine sulfate
What is OROS hydromorphone HCL ; Morphine sulfate?
How does OROS hydromorphone HCL ; Morphine sulfate work?
What is OROS hydromorphone HCL ; Morphine sulfate used for?
Who makes OROS hydromorphone HCL ; Morphine sulfate?
What drug class is OROS hydromorphone HCL ; Morphine sulfate in?
What development phase is OROS hydromorphone HCL ; Morphine sulfate in?
What are the side effects of OROS hydromorphone HCL ; Morphine sulfate?
What does OROS hydromorphone HCL ; Morphine sulfate target?
Related
- Drug class: All Opioid analgesic drugs
- Target: All drugs targeting Mu opioid receptor
- 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 HCL ; Morphine sulfate vs similar drugs
- Pricing: OROS hydromorphone HCL ; Morphine sulfate cost, discount & access