NAPRELAN (naproxen sodium)
Naprelan is a medication used for patients suffering from various inflammatory and painful joint conditions, such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. It also helps patients with acute episodes of gout as well as soft tissue inflammation like tendinitis and bursitis. Beyond chronic conditions, it treats primary dysmenorrhea and provides relief for general mild to moderate pain.
How NAPRELAN Works
This drug works by inhibiting the COX-1 and COX-2 enzymes, which blocks the synthesis of prostaglandins in peripheral tissues. Because prostaglandins are responsible for mediating inflammation and sensitizing nerves to pain, reducing their production helps decrease swelling and discomfort. It also possesses antipyretic properties to help lower fever.
Details
- Status
- Prescription
- First Approved
- 1996-01-05
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
NAPRELAN Approval History
What NAPRELAN Treats
8 indicationsNAPRELAN is approved for 8 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid Arthritis
- Osteoarthritis
- Ankylosing Spondylitis
- Tendinitis
- Bursitis
- Gout
- Primary Dysmenorrhea
- Pain
NAPRELAN Boxed Warning
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events 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 [see Warnings and Precautions ( 5.1 )] . NAPRELAN is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindication...
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events 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 [see Warnings and Precautions ( 5.1 )] . NAPRELAN is 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 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 GASTROINTESTINAL EVENTS 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 ) NAPRELAN® is contraindicated in the setting of coronary artery bypass graft (CABG) surgery ( 4 , 5.1 ) NSAIDs 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 ( 5.2 )
NAPRELAN 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 NAPRELAN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NAPRELAN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to NAPRELAN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04145518 MCUP | EH19-040 R01HD098193-01A1 | Ph 4 | completed | Mechanistic Characterization of Uterine Pain |
| NCT04015596 results posted | 2019P000623 | Ph 4 | terminated | Trial of Naproxen Sodium for the Treatment of OCD in Children With PANDAS |
| NCT05761574 | CCSPAA005199 CCSPAA005199 | Ph 3 | completed | A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain |
| NCT05982392 | 2889 | Ph 2, Ph 3 | completed | Effect of Preoperative Tramadol and Naproxen Sodium on Post Operative Pain |
| NCT01107236 | ICP-109-201 | Ph 2 | completed | Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction |
| NCT03291418 | ATB-346-P2GIS | Ph 1, Ph 2 | completed | To Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects |
| NCT01090050 results posted | 112839 | Ph 4 | completed | Treximet in the Treatment of Chronic Migraine |
| NCT01300546 results posted | 114933 | Ph 4 | completed | Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine |
| NCT00692016 Keifer | 13080 | Ph 1 | completed | Fast & Fed Pharmacokinetic (PK) Study |
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.
NAPRELAN FDA Label Details
Indications & Usage
FDA Label (PDF)NAPRELAN is indicated for the treatment of Rheumatoid Arthritis; Osteoarthritis; Ankylosing Spondylitis; Tendinitis; Bursitis; Gout; Primary Dysmenorrhea; Pain.
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events 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 ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.