To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Naprelan, Once-a-day Formulation of Naproxen Cleared by FDA URL: http://www.pslgroup.com/dg/6032.htm Doctor's Guide January 9, 1996
ATHLONE, Ireland, and PHILADELPHIA, -- Jan. 9, 1996 -- Naprelan(R) (naproxen sodium), a once-a-day formulation of the popular arthritis medication Naprosyn(R) (naproxen) has been cleared for marketing by the Food and Drug Administration (FDA), Elan Corporation, plc. (NYSE: ELN) and Wyeth Ayerst Laboratories, a division of American Home Products Corporation (NYSE: AHP)announced today. American Home Products is the number one U.S. supplier of prescription anti-arthritic products. Naprelan(R) is the first prescription product to offer convenient once-a-day dosing of naproxen, a medication long considered a standard in arthritis treatment. Naproxen or naproxen sodium-based products account for nearly one in every five prescriptions written for non- steroidal anti-inflammatory drugs (NSAIDS) in the United States(1). (Naproxen sodium, a sodium salt formulation of naproxon, provides for more rapid absorption). Naprelan(R) tablets use a proprietary delivery system, IPDAS(TM) (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 (30% approximately) 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 which 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). "While most once-a-day NSAIDs provide extended relief at the expense of immediate relief, Naprelan(R) offers patients rapid onset with sustained action, while minimizing the risk of local gastrointestinal irritation" said Marc Deitch, M.D., Senior Vice President, Medical Affairs and Medical Director for Wyeth Ayerst Laboratories. "This is an important therapeutic advantage for people with arthritis who desire rapid symptomatic relief but want the convenience of medication that is taken only once a day." Naprosyn(R) has been used safely and effectively worldwide for 20 years and is one of the NSAIDs most widely used in the treatment of osteoarthritis and rheumatoid arthritis. Numerous clinical studies have demonstrated the efficacy and safety profile of Naprosyn(R). Naprelan(R) offers the same efficacy and safety profile as Naprosyn(R) with the added advantage of once-a-day dosing. The most frequent complaints relate to the gastrointestinal tract. In patients treated chronically with NSAID therapy, serious gastrointestinal toxicity such as perforation, ulceration and bleeding can occur. "The approval of Naprelan(R) marks another important milestone in the development of Elan" said Donal Geaney, Elan's President & Chief Executive Officer. "This product which uses our unique IPDAS(TM) delivery technology, will benefit arthritis sufferers by providing safe and convenient medication to combat this debilitating disease." Robert Essner, President of Wyeth Ayerst Laboratories notes that "Arthritis takes a tremendous toll on individuals, and experience tells us that no one arthritis medication is right for everyone. The approval of Naprelan(R) is very exciting because it adds another product to our well established line of NSAIDs and allows us to offer more options for physicians and patients suffering from the chronic pain of arthritis. The spectrum of products also enables us to better serve the needs of our large managed care customers, in effect offering 'one-stop shopping' for all of their NSAID needs." Elan Corporation is a leading worldwide drug delivery company with innovative drug absorption technologies designed to improve patient care in a cost effective manner. Its principal research and manufacturing facilities are in Ireland and the United States of America. Wyeth Ayerst Laboratories is a major research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular and metabolic disease therapies, central nervous system drugs, anti-inflammatory agents, vaccines, infant nutritionals and generic pharmaceuticals. American Home Products Corporation ranks among the top companies in the world in sales of pharmaceuticals and health-care products. It is also a leader in agricultural products, animal health care, medical devices and food products. NOTES: 1. IMS Data 2. 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. 3. Cooper, SA, Gaston, G, Devane J. A double blind randomized, parallel group study of the acute analgesic efficacy of Naprelan, December 1994 Data on file, Wyeth Ayerst Laboratories. 4. Caldwell, J. Keller M. A comparison of Naprelan versus Naprosyn in the treatment of rheumatoid arthritis, December 1994. Data on file, Wyeth Ayerst Laboratories. 5. Serge E. Long term experience with naproxen: Open label cohort survey of nearly 900 rheumatoid arthritis and osteoarthritis patients. Curr Ther Res 1980; 28:47-60 Naprosyn(R) is a registered trademark of Roche Laboratories. CONTACT: Donal J. Geaney, President & CEO of Elan Corporation, plc., 011-353-902-95000, or Audrey Ashby, Director of Public Relations of Wyeth Ayerst Laboratories, 610-971-5823, or Brian Crotty, Group Vice President-Communications of Elan Corporation, plc., 011-353-902-95000/ (ELN AHP). --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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