NDAORALTABLET
Approved
Jan 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
35
Data completeness
4/8 — Partial
ALEVE (naproxen sodium) by Bayer is analgesic, anti-inflammatory, and antipyretic properties. First approved in 1994.
Drug data last refreshed 4h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Aleve is a branded formulation of naproxen sodium, an oral nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief and inflammation management. It works by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes to reduce prostaglandin synthesis, thereby decreasing pain signaling and inflammatory mediators. The sodium salt formulation allows for faster onset of action compared to standard naproxen.
LOE Approaching
Aleve faces moderate competitive pressure in a mature OTC/generic NSAID market with declining exclusivity; expect smaller brand teams focused on legacy brand management and consumer awareness maintenance.
Mechanism of Action
analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of naproxen, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Naproxen sodium is a potent inhibitor of prostaglandin synthesis in vitro . Naproxen…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (35)
A Multiple-Dose Safety Study of Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents With Orthodontic Pain
Started Jan 2024
0Orthodontic Pain
A Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Pain
Started Sep 2023
24 enrolled
Orthodontic Pain
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
Started Sep 2023
143 enrolled
Pain
A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain
Started May 2023
447 enrolled
Pain
A Study to Learn How Well a Single Dose of the Study Treatment Naproxen Sodium and Caffeine Combined in One Tablet (Fixed-dose Combination) Works to Relieve Pain After Dental Surgeries Compared to the Single Ingredients and to Placebo
Started Sep 2022
541 enrolled
Postoperative Dental Pain
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.