NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (esomeprazole magnesium)
This combination medication is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in adults, and juvenile idiopathic arthritis in adolescents (12 years and older weighing at least 38 kg). It is specifically designed for patients at risk of developing naproxen-associated gastric ulcers. By combining naproxen (an NSAID) with esomeprazole magnesium (a proton pump inhibitor), it manages joint pain and inflammation while reducing the risk of stomach complications. It is not recommended for the initial treatment of acute pain because the absorption of naproxen is delayed in this formulation.
How NAPROXEN AND ESOMEPRAZOLE MAGNESIUM Works
This medication consists of an immediate-release esomeprazole magnesium layer surrounding an enteric-coated naproxen core. Esomeprazole is released first in the stomach to decrease acid production by inhibiting the $H^+/K^+$-ATPase (proton pump) in the gastric parietal cells. The enteric coating then prevents the release of naproxen until it reaches the higher pH of the small intestine. Naproxen provides analgesic and anti-inflammatory effects by inhibiting cyclooxygenase-1 and 2 (COX-1 and COX-2), which leads to a reduction in the synthesis of inflammatory prostaglandins.
Details
- Status
- Prescription
- First Approved
- 2020-02-18
- Routes
- ORAL
- Dosage Forms
- TABLET, DELAYED RELEASE
Companies
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM Approval History
What NAPROXEN AND ESOMEPRAZOLE MAGNESIUM Treats
5 indicationsNAPROXEN AND ESOMEPRAZOLE MAGNESIUM is approved for 5 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Osteoarthritis
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- Juvenile Idiopathic Arthritis
- Gastric Ulcer
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM Boxed Warning
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Non-Steroidal Anti-inflammatory Drugs (NSAIDs), a component of naproxen and esomeprazole magnesium delayed-release tablets, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1) ] . Naproxen and esomeprazole magnesiu...
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Non-Steroidal Anti-inflammatory Drugs (NSAIDs), a component of naproxen and esomeprazole magnesium delayed-release tablets, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1) ] . Naproxen and esomeprazole magnesium delayed-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) , and Warnings and Precautions (5.1) ] . Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs, a component of naproxen and esomeprazole magnesium delayed-release tablets cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2) ] . WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINALEVENTS See full prescribing information for complete boxed warning. Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. ( 5.1 ) Naproxen and esomeprazole magnesium delayed-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. ( 4 , 5.1 ) NSAIDs, including naproxen, a component of naproxen and esomeprazole magnesium delayed-release tablets, cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration,
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in NAPROXEN AND ESOMEPRAZOLE MAGNESIUM's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NAPROXEN AND ESOMEPRAZOLE MAGNESIUM treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01135472 | 08197 | Ph 1 | completed | Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM FDA Label Details
Indications & Usage
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM is indicated for the treatment of Osteoarthritis; Rheumatoid Arthritis; Ankylosing Spondylitis; Juvenile Idiopathic Arthritis; Gastric Ulcer.
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Non-Steroidal Anti-inflammatory Drugs (NSAIDs), a component of naproxen and esomeprazole magnesium delayed-release tablets, cause an increased risk of serious cardiovascular thrombotic events, includ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.