To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Pain Relief for Sufferers of Osteoarthritis of the Knee URL: http://www.pslgroup.com/dg/35D02.htm Doctor's Guide August 28, 1997
NEW YORK -- August 28, 1997 -- Physicians in the United States treating osteoarthritis of the knee and the patients who suffer from this common and often extremely painful and debilitating degenerative joint disease now have an important new therapeutic option. Hyalgan(R) (sodium hyaluronate), developed by Fidia Pharmaceutical and marketed in the United States by Sanofi Pharmaceuticals, is the first agent in a new class of treatments for osteoarthritis of the knee. Hyalgan contains hyaluronate, a natural viscoelastic modifying agent found in the knee joint that acts as a lubricant and shock absorber. A course of Hyalgan treatment -- which consists of 5 injections, administered directly into the knee, over 4 weeks -- will relieve pain in a majority of patients for 6 months without the safety concerns of nonsteroidal anti-inflammatory drug (NSAID) therapy. In many patients, the effect of Hyalgan is likely to last even longer than 6 months. The body's own hyaluronate is present in particularly high amounts in joint tissues and the synovial fluid that fills the joints and plays a key role in joint function. In patients with osteoarthritis, the quality and quantity of hyaluronate in the joint fluid and tissues may be deficient. Hyalgan received clearance for marketing recently from the United States Food and Drug Administration for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy, and to simple analgesics, e.g., acetaminophen. The product is available in the United States from Sanofi Pharmaceuticals and its co-promotion partner OrthoLogic under a licensing agreement with Fidia Pharmaceutical of Padua, Italy. Approximately 1 million patients in 20 countries have been treated with Hyalgan over the past decade. "Hyalgan is a useful agent for the many individuals who have osteoarthritis of the knee and do not respond to, or are intolerant of, other therapies," says Roy D. Altman, M.D., Chief of the Arthritis Division and Professor of Medicine at the University of Miami School of Medicine, who was a Hyalgan clinical investigator. "Hyalgan is also useful for people who may be anticipating going to surgery as a way of delaying that surgery." "Hyalgan is an important therapeutic option for the millions of patients who suffer from osteoarthritis of the knee," notes Kathy Young, Director of Marketing, Internal Medicine, Sanofi Pharmaceuticals. "There is an obvious need for an alternative to currently available pharmacological therapy, particularly non-steroidal anti-inflammatory drugs with their risk of serious adverse events. We expect that Hyalgan will be welcomed by physicians and patients alike and will be a major new brand for Sanofi." NSAIDs have traditionally been the mainstay of drug treatment for osteoarthritis. But many experts have serious concerns about the risks associated with their use. The risk of drug interactions and serious adverse events -- including gastrointestinal problems, deterioration of renal and hepatic function, and iron deficiency anemia -- is particularly relevant since the elderly are most at risk of osteoarthritis. Many patients admitted to hospitals with acute gastrointestinal bleeding are taking NSAIDs. "Sodium hyaluronate for osteoarthritis of the knee represents an efficacious and safe alternative to current treatments," notes Kenneth D. Brandt, M.D., Head, Rheumatology Division, Indiana University School of Medicine, Indianapolis, and a Hyalgan clinical investigator. "Patients in our study, who were all suffering from chronic pain due to osteoarthritis of the knee, typically did not get relief from simple analgesics, or were often unable to tolerate the side effects of NSAIDs." In the United States, an estimated 16 million individuals suffer from osteoarthritis, according to the Arthritis Foundation, and another million will develop osteoarthritis each year. Osteoarthritis accounts for 7 million physician visits a year, with osteoarthritis of the knee accounting for most visits. Women are more commonly affected (11.7 million) than men (4.1 million). The incidence of osteoarthritis and the cost to society is rising sharply, as the proportion of elderly people in the population grows. Sanofi Pharmaceuticals is the U.S. pharmaceutical subsidiary of Sanofi, a global healthcare company with headquarters in Paris. Hyalgan enhances Sanofi's growing line of products for bone and skeletal disorders. Sanofi recently launched Skelid(R) (tiludronate disodium) for Paget's disease of bone and is studying Skelid for an additional indication. Sanofi also markets Plaquenil(R) (hydroxychloroquine sulfate) for the treatment of rheumatoid arthritis and other diseases. OrthoLogic develops, manufactures, and markets proprietary technologically advanced orthopedic devices designed to promote the healing of musculoskeletal tissue. The company headquarters are in Phoenix. Fidia is an Italian pharmaceutical company that specializes in research and development of products based on natural compounds. The company is a leader in the development and commercialization of hyaluronic acid-based products for rheumatology, dermatology, and ophthalmology applications. Fidia supplies Hyalgan in finished form to Sanofi for marketing in the United States. --------------------------------------------------------------------------------------------- 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.