To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Clears Flonase Nasal Spray For Young Children URL: http://www.pslgroup.com/dg/424FE.htm Doctor's Guide November 3, 1997
RESEARCH TRIANGLE PARK, NC -- November 3, 1997 -- From the classroom to the playground, allergic rhinitis can have a serious impact on a child's active lifestyle. But now there's great news for the many young nasal allergy sufferers as the United States Food and Drug Administration (FDA) has cleared for marketing Glaxo Wellcome Inc.'s Flonase(R) (fluticasone propionate) Nasal Spray, 0.05% (50 mcg/actuation), for treatment of seasonal and perennial allergic rhinitis in children four years and older. The supplementary NDA for the drug represents an extension of the product to include younger children. Flonase is now the first prescription nasal allergy medication available for children as young as four. With its once-a-day dosing schedule, children can take the product in the morning and avoid taking their medication at school. Flonase has a fast onset of action with relief that lasts all day long and has an excellent safety profile. Many patients may experience relief in as soon as 12 hours. Maximum relief may take several days. Effectiveness of the product requires that it be used regularly. "Allergic rhinitis can have a significant impact on a child's daily activities," said William Lumry, M.D., an allergist in Dallas, Texas, and a clinical investigator for Flonase. "Flonase will be a welcomed treatment option for the many young children who suffer from nasal allergy symptoms." Allergic rhinitis is the most prevalent chronic disease in the U.S., affecting more than 35 million people, including 20 percent of all school-age children. Allergic rhinitis can affect a child's education -- students with all types of allergies miss three million school days annually. When they are in school, some young allergy sufferers may have difficulty concentrating due to lack of sleep or irritability caused by their allergy symptoms. In addition to disruptive allergy symptoms, some allergy medications cause children to become drowsy or jittery. However, Flonase does not cause drowsiness or jitteriness and is not addictive. The product works by reducing the inflammation of the nasal passages, thereby relieving the accompanying nasal allergy symptoms, including nasal stuffiness. Antihistamines, used by many allergy sufferers, relieve some allergic symptoms, but generally are not effective in treating one of the primary causes of patient discomfort -- nasal congestion. Flonase is a water-based, once-a-day, anti-rhinitic prescription nasal spray. It is not indicated for the treatment of nonallergic rhinitis. The safety and efficacy of Flonase were studied in clinical trials involving 500 children aged four to 11. The studies looked at its safety and efficacy in treating patients with seasonal and perennial allergic rhinitis and reported significant reductions in allergic rhinitis symptoms including nasal stuffiness, nasal itching, runny nose and sneezing. Seasonal allergic rhinitis -- more commonly referred to as hay fever -- is triggered by the immune system's response to pollens (e.g., tree pollen in the spring, grasses in the spring and summer and weeds in the fall). Perennial allergic rhinitis is set off by house dust, mold, smoke and animal dander and is often mistaken for a cold. Common nasal allergy symptoms include runny nose, sneezing, itching and nasal congestion, which is the most frequent complaint. More information on: Flonase, Glaxo Wellcome Inc. --------------------------------------------------------------------------------------------- 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.