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VIMOVO 500/20
VIMOVO combines naproxen (an NSAID) with esomeprazole (a proton pump inhibitor) to reduce pain and inflammation while protecting the stomach from NSAID-induced ulcers.
VIMOVO combines naproxen (an NSAID) with esomeprazole (a proton pump inhibitor) to reduce pain and inflammation while protecting the stomach from NSAID-induced ulcers. Used for Osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients at risk for NSAID-induced gastric ulcers.
At a glance
| Generic name | VIMOVO 500/20 |
|---|---|
| Also known as | naproxen/esomeprazole |
| Sponsor | Amgen |
| Drug class | NSAID with proton pump inhibitor combination |
| Target | COX-1/COX-2 (naproxen); H+/K+-ATPase (esomeprazole) |
| Modality | Small molecule |
| Therapeutic area | Rheumatology / Pain Management |
| Phase | FDA-approved |
Mechanism of action
Naproxen inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain. Esomeprazole suppresses gastric acid secretion by inhibiting the H+/K+-ATPase pump, protecting the gastric mucosa from NSAID-related damage and ulceration.
Approved indications
- Osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients at risk for NSAID-induced gastric ulcers
Common side effects
- Dyspepsia
- Diarrhea
- Gastric ulcer (reduced vs. NSAID alone)
- Headache
- Nausea
Key clinical trials
- A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA) (PHASE4)
- Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis (PHASE3)
- Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis (PHASE3)
- A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation (PHASE1)
- Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen (PHASE3)
- Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen (PHASE3)
- Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec (PHASE3)
- A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 (VIMOVO) (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:
- VIMOVO 500/20 CI brief — competitive landscape report
- VIMOVO 500/20 updates RSS · CI watch RSS
- Amgen portfolio CI