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Comparator: acetaminophen + codeine
Acetaminophen reduces fever and pain through central nervous system effects, while codeine is an opioid agonist that enhances analgesia and suppresses cough.
Acetaminophen reduces fever and pain through central nervous system effects, while codeine is an opioid agonist that enhances analgesia and suppresses cough. Used for Moderate pain, Pain with fever.
At a glance
| Generic name | Comparator: acetaminophen + codeine |
|---|---|
| Sponsor | Organon and Co |
| Drug class | Opioid analgesic combination |
| Target | Mu-opioid receptor (codeine component); prostaglandin synthesis inhibition (acetaminophen component) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Acetaminophen's exact mechanism is not fully understood but is believed to involve inhibition of prostaglandin synthesis in the central nervous system and modulation of serotonergic and cannabinoid pathways. Codeine is a prodrug that is metabolized to morphine and acts as a mu-opioid receptor agonist, providing additional analgesic and antitussive effects. The combination provides synergistic pain relief for moderate pain conditions.
Approved indications
- Moderate pain
- Pain with fever
Common side effects
- Drowsiness
- Dizziness
- Constipation
- Nausea
- Respiratory depression
Key clinical trials
- Opioid-Free Pain Protocol After Shoulder Arthroplasty (PHASE4)
- Study in Subjects Undergoing Complete Abdominoplasty (PHASE2)
- A Multicenter Active Comparator Study of HC-ER in Adults Following Bunionectomy Surgery (PHASE2)
- A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092) (PHASE3)
- Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain (PHASE1, PHASE2)
- Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED) (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)
- Bioequivalence Study of One Tablet of Paracetamol 1000 mg + Codeine 30 mg vs. Two Tablets of Paracetamol 500 mg + Codeine 30 mg (PHASE1)
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 |