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tramadol HCl ER; celecoxib
This combination product uses tramadol (an opioid agonist and monoamine reuptake inhibitor) for pain relief and celecoxib (a selective COX-2 inhibitor) for anti-inflammatory effects.
This combination product uses tramadol (an opioid agonist and monoamine reuptake inhibitor) for pain relief and celecoxib (a selective COX-2 inhibitor) for anti-inflammatory effects. Used for Moderate to moderately severe chronic pain (Phase 3 indication).
At a glance
| Generic name | tramadol HCl ER; celecoxib |
|---|---|
| Sponsor | Bausch Health Americas, Inc. |
| Drug class | Opioid analgesic + selective COX-2 inhibitor (NSAID) |
| Target | Opioid receptors (μ, δ, κ); monoamine transporters (SERT, NET); COX-2 |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Tramadol HCl ER provides extended-release opioid analgesia while also inhibiting reuptake of serotonin and norepinephrine, enhancing pain modulation through multiple pathways. Celecoxib selectively inhibits cyclooxygenase-2 (COX-2), reducing prostaglandin synthesis and inflammation. The combination targets both nociceptive pain and inflammatory components of pain conditions.
Approved indications
- Moderate to moderately severe chronic pain (Phase 3 indication)
Common side effects
- Nausea
- Dizziness
- Constipation
- Headache
- Gastrointestinal upset
- Somnolence
Key clinical trials
- Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty? (PHASE2)
- A Study Comparing the Effectiveness and Safety of Extended Release Tramadol HCl at 100 mg, 200 mg and 300 mg Doses to Placebo for the Treatment of Moderate to Severe Pain Due to Osteoarthritis (OA) (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:
- tramadol HCl ER; celecoxib CI brief — competitive landscape report
- tramadol HCl ER; celecoxib updates RSS · CI watch RSS
- Bausch Health Americas, Inc. portfolio CI