EC-NAPROSYN

LOE Approaching

naproxen

NDAORALTABLET, DELAYED RELEASE
Approved
Oct 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20

Mechanism of Action

Cyclooxygenase Inhibitors

Pharmacologic Class:

Nonsteroidal Anti-inflammatory Drug

Indications (1)

rheumatoid arthritis

Clinical Trials (5)

NCT05845008Phase 3Withdrawn

A Multiple-Dose Safety Study of Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents With Orthodontic Pain

Started Jan 2024
0
Orthodontic Pain
NCT05844995Phase 1Completed

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
NCT05868122Phase 3Completed

A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy

Started Sep 2023
122 enrolled
Pain
NCT05761574Phase 3Completed

A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain

Started May 2023
447 enrolled
Pain
NCT05485805Phase 3Completed

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
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers