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Naproxen Sodium (Aleve)
Naproxen sodium inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin production, thereby decreasing inflammation, pain, and fever.
Naproxen sodium inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin production, thereby decreasing inflammation, pain, and fever. Used for Mild to moderate pain, Fever, Inflammation associated with arthritis and musculoskeletal conditions.
At a glance
| Generic name | Naproxen Sodium (Aleve) |
|---|---|
| Sponsor | Seattle Institute for Biomedical and Clinical Research |
| Drug class | Nonsteroidal anti-inflammatory drug (NSAID) |
| Target | COX-1, COX-2 |
| Modality | Small molecule |
| Therapeutic area | Pain Management, Rheumatology, Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that non-selectively blocks COX-1 and COX-2 enzymes. By inhibiting these enzymes, it reduces the synthesis of prostaglandins, which are key mediators of inflammation, pain signaling, and fever. The sodium salt formulation allows for faster absorption and more rapid onset of action compared to standard naproxen.
Approved indications
- Mild to moderate pain
- Fever
- Inflammation associated with arthritis and musculoskeletal conditions
Common side effects
- Gastrointestinal upset (dyspepsia, nausea)
- Abdominal pain
- Headache
- Dizziness
- Increased cardiovascular risk (with chronic use)
- Renal impairment (with chronic use)
Key clinical trials
- Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis (NA)
- Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis (PHASE4)
- A Study of SJP-001 in Comparison With Fexofenadine and Naproxen Administered With Alcohol (PHASE1, PHASE2)
- Non-Steroidal Anti-Inflammatory Drug (NSAID) Response and Central Sensitization of Pain in Women With Dysmenorrhea (PHASE4)
- Suzetrigine Versus Usual-care Opioids for Postop Pain in Sports (PHASE4)
- Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain (PHASE2, PHASE3)
- Effect of Extracorporeal Shock Wave Therapy (ESWT) and Phonophoresis Treatment in Patients With Lateral Epicondylitis (NA)
- Accessible Acupuncture for the Warrior With Acute Low Back Pain (NA)
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 |
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