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Comparator: oxycodone and acetaminophen
This is a fixed-dose combination of oxycodone (a mu-opioid receptor agonist) and acetaminophen (a non-opioid analgesic) that provides pain relief through dual mechanisms.
This is a fixed-dose combination of oxycodone (a mu-opioid receptor agonist) and acetaminophen (a non-opioid analgesic) that provides pain relief through dual mechanisms. Used for Moderate to moderately severe acute or chronic pain.
At a glance
| Generic name | Comparator: oxycodone and acetaminophen |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Opioid analgesic combination |
| Target | Mu-opioid receptor (oxycodone); COX inhibition and TRPV1 modulation (acetaminophen) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Oxycodone binds to mu-opioid receptors in the central nervous system to modulate pain perception and transmission. Acetaminophen works through distinct mechanisms including inhibition of prostaglandin synthesis and modulation of descending pain pathways. The combination provides synergistic analgesia for moderate to moderately severe pain management.
Approved indications
- Moderate to moderately severe acute or chronic pain
Common side effects
- Nausea
- Constipation
- Dizziness
- Drowsiness
- Vomiting
- Pruritus
Key clinical trials
- Opioid-Free Pain Protocol After Shoulder Arthroplasty (PHASE4)
- Pain Management Study (PHASE4)
- Study in Subjects Undergoing Complete Abdominoplasty (PHASE2)
- A Randomized-controlled Trial of Post-operative Opiate Quantities After Urogynecologic Surgery (NA)
- Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury (PHASE3)
- A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Acute Pain and Opioid-Induced Nausea and Vomiting (OINV) (PHASE3)
- A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-183) (PHASE3)
- A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-182) (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 |
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