Home » Drug Information » Recently Approved Drugs » 1996
Medical Areas: Endocrinology | Musculoskeletal | Rheumatology
Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Elan, Wyeth-Ayerst Laboratories
Approval Status: Approved January 1996
Treatment Area: osteoarthritis, rheumatoid arthritis
Naprelan (naproxen sodium) is the once-a-day formulation of the
arthritis medication Naprosyn (naproxen). Naprelan, a sodium salt
formulation of Naprosyn, provides for more rapid absorption.
Naprelan tablets use a proprietary delivery system, IPDAS
(Intestinal Protective Drug Absorption System), a matrix of
naproxen sodium with immediate and controlled release components.
Upon ingestion, and after rapid disintegration of the tablet
matrix, an initial fraction (approximately 30%) of the medication
is released for rapid systemic absorption achieving onset of
analgesic action within 30 minutes. In addition, a
sustained-release component of microparticles provide an extended
absorption phase that both minimizes local gastrointestinal
concentrations and prolongs therapeutic systemic levels of the
drug, enabling 24-hour duration of action and once-a-day dosing
(2-4).
The most frequent complaints relate to the gastrointestinal
tract. In subjects treated chronically with Naprelan, a
non-steroidal anti-inflammatory drug, serious gastrointestinal
toxicity such as perforation, ulceration, and bleeding can
occur.
Cooper, SA, Gaston, G, Devane J. A double-blind, randomized,
parallel, group study of the acute analgesic efficacy of Naprelan
in patients following oral surgery. February 1994. Data on
file, Wyeth-Ayerst Laboratories.
A double-blind, randomized, parallel, group study of the
acute analgesic efficacy of Naprelan. December 1994. Data on
file, Wyeth-Ayerst Laboratories.
Caldwell, J. Keller M. A Comparison of Naprelan versus
Naprosyn in the treatment of rheumatoid arthritis. December
1994. Data on file, Wyeth-Ayerst Laboratories.
Serge E. Long term experience with naproxen: Open label
cohort survey of nearly 900 rheumatoid arthritis and osteoarthritis
patients. Current Ther. Res 1980; 28:47-60.
Naproxen or naproxen sodium-based products account for
approximately one in every five prescriptions written for
non-steroidal anti-inflammatory drugs in the United States.