To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Lodine Once-Daily Version Granted Marketing Clearance by the FDA URL: http://www.pslgroup.com/dg/D4FA.htm Doctor's Guide October 29, 1996
RADNOR, Pa.—Oct. 29, 1996 -- Lodine(R) XL Allows More Convenient Dosing of Popular Arthritis Medication -- Wyeth-Ayerst Laboratories, a division of American Home Products Corporation (NYSE:AHP), announced today that Lodine(R) XL (etodolac extended-release tablets), a once-daily version of the popular arthritis medication Lodine(R) (etodolac tablets and capsules), has been granted marketing clearance by the U.S. Food and Drug Administration (FDA). Like the original formulation, Lodine XL provides relief from the pain and inflammation of osteoarthritis and rheumatoid arthritis,(1) but with once-daily convenience.(2) Lodine XL is available in 400 mg and 600 mg tablets, and may cost less than Lodine when cost is based on average wholesale price, which is a published list price and may not necessarily reflect actual price to pharmacists or consumers. Cost is an important issue for patients with chronic conditions, as is a simple dosing schedule. Lodine XL (etodolac extended-release tablets) provides arthritis patients not only with affordable and effective pain relief, but also with an easy-to-follow and easy-to-remember treatment schedule that may help them better manage their condition. Today's FDA decision granting marketing clearance to Lodine XL follows closely on the heels of two other recent FDA decisions regarding Lodine (etodolac tablets and capsules): marketing clearance of a 500 mg dosage strength, as well as a new indication for the treatment of rheumatoid arthritis (RA). Lodine, a potent analgesic and anti-inflammatory medication, is one of the most popular branded nonsteroidal anti-inflammatory medications (NSAIDs) available. More than five million prescriptions were filled for Lodine in the United States in the past year.(3) As with all NSAIDs, the most common complaints relate to the gastrointestinal tract.(4) NSAIDs represent a broad category of drugs that includes more than 20 different branded compounds on the market and often are considered first-line therapy for arthritis, a condition that affects one in seven Americans.(5) Clinical trials have established that Lodine XL is effective in managing pain and inflammation. In one study of Lodine XL used for the treatment of osteoarthritis of the knee, 800 mg of Lodine XL (etodolac extended-release tablets) taken once daily was found to be as effective as 400 mg of Lodine (etodolac tablets and capsules) taken three times a day.(6) "These clinical trials, along with more than a dozen controlled studies and years of clinical experience with the original formulation of Lodine, show that both forms of Lodine effectively relieve pain and inflammation," says Marc W. Deitch, M.D., Senior Vice President, Medical Affairs, and Medical Director at Wyeth-Ayerst Laboratories. "Lodine XL will provide physicians with a new option for managing patients with arthritis symptoms." 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, and generic pharmaceuticals. American Home Products is one of the world's largest research-based pharmaceutical and health care products companies and is a leading developer, manufacturer and marketer of prescription drugs and over-the-counter medications. It is also a leader in vaccines, biotechnology, crop protection products, animal health care and medical devices. References 1. Data on file. Wyeth-Ayerst Laboratories. 2. Data on file. Wyeth-Ayerst Laboratories. 3. Data on file. Wyeth-Ayerst Laboratories. 4. Data on file. Wyeth-Ayerst Laboratories. 5. Arthritis Foundation Fact Sheet, 1995. 6. Data on file. Wyeth-Ayerst Laboratories. --------------------------------------------------------------------------------------------- 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. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.