A Comprehensive Monograph on Naproxen (DrugBank ID: DB00788): Pharmacology, Clinical Efficacy, and Comparative Risk-Benefit Analysis

1.0 Executive Summary of Naproxen

Naproxen is a well-established small molecule drug belonging to the propionic acid class of nonsteroidal anti-inflammatory drugs (NSAIDs).[1] First approved for prescription use in 1976 and later for over-the-counter (OTC) access in 1994, it has become a cornerstone therapy for managing pain, inflammation, and fever across a wide spectrum of clinical scenarios.[3] Its therapeutic utility is derived from its core pharmacological mechanism: the non-selective and reversible inhibition of both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes.[1] By blocking these enzymes, naproxen effectively reduces the synthesis of prostaglandins, which are critical mediators in the pathways of pain, inflammation, and pyresis.[1]

Clinically, naproxen is indicated for numerous conditions, including chronic inflammatory disorders like rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis, as well as acute conditions such as gout, tendinitis, bursitis, and primary dysmenorrhea.[1] Its efficacy in these areas is supported by decades of clinical use and numerous studies. The development of various formulations, including immediate-release, extended-release, and gastro-protective combination products, has further solidified its place in the therapeutic armamentarium.[1]