To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves New Allegra (Fexofenadine) Dosage For Allergic Rhinitis URL: http://www.pslgroup.com/dg/177906.htm Doctor's Guide February 28, 2000
PARSIPPANY, NJ -- February 28, 2000 -- Allegra(R) (fexofenadine HCl) 180-mg tablets, a new dosage form for the Allegra family of products, may help patients 12 and older experiencing allergies do a "180" -- from suffering to relief. Aventis Pharmaceuticals announced that Allegra 180-mg tablets have been approved by the U.S. Food and Drug Administration (FDA). Allegra 180 mg is a once-daily nonsedating antihistamine for the relief of seasonal allergic rhinitis (SAR) and is available by prescription. Allergy sufferers' symptoms, such as runny nose and itchy, watery eyes, can hinder the enjoyment of many outdoor activities. The safety and efficacy of Allegra in treating symptoms of SAR was examined in a recent clinical study. In this study, Allegra 180 mg, administered once daily, was superior to placebo in alleviating symptoms of SAR including sneezing, rhinorrhea, itchy nose/mouth/ throat, itchy/watery/red eyes and was well tolerated. "This study highlights the relief in seasonal allergic rhinitis symptoms that Allegra may provide to patients," said Thomas Casale, M.D., Director of the Nebraska Medical Research Institute, and Clinical Professor of the University of Nebraska Medical School and Creighton University in Papillon, Nebraska. "In addition to these improvements, Allegra 180 mg allows seasonal allergy sufferers 12 and older the flexibility to take their allergy medication once-a-day, at a time that is convenient with their schedule to help them experience 24-hour symptomatic relief. This new dosing further strengthens Allegra as a nonsedating antihistamine option for seasonal allergy sufferers." "I like to spend time outdoors -- camping, boating and hiking -- but my seasonal allergy symptoms make it less enjoyable," said Nora Treat, Gretna, Nebraska. "After I was given nondrowsy Allegra 180 mg in a clinical study, I felt relief from my allergy symptoms with just one tablet a day." In addition to Allegra 180 mg, the FDA approved additional line extensions for Allegra that will be available by prescription later this year. These include: -- For the relief of seasonal allergy symptoms now in children ages 6 to 11 years, Allegra 30-mg tablets, twice daily. Seasonal allergies affect as many as 10 percent of children each year; and -- For the relief of chronic idiopathic urticaria (CIU), in patients 12 years and older, 60-mg tablets or capsules, twice daily and for children ages 6 to 11 years, doses of 30 mg, twice daily. "The addition of these new line extensions allows the Allegra family to provide treatment options for seasonal allergic rhinitis and CIU sufferers aged 6 years and older," said Frank Ciriello, vice president of Marketing Therapeutics at Aventis Pharmaceuticals. "We are confident that the nondrowsy Allegra family of products can help a wide range of sufferers experience significant symptom relief." Allegra(R) (fexofenadine HCl) is well tolerated with side effects similar to placebo. Compared to placebo, the most commonly reported adverse events with Allegra 60-mg capsules is cold or flu (2.5 percent vs. 1.5 percent), nausea (1.6 percent vs. 1.5 percent), and menstrual pain (1.5 percent vs. 0.3 percent) in SAR patients 12 years and older. The most commonly reported adverse events with Allegra 60-mg tablets in CIU patients 12 years and older are back pain (2.2 percent vs. 1.1 percent), sinusitis (2.2 percent vs. 1.1 percent), dizziness (2.2 percent vs. 0.6 percent), and drowsiness (2.2 percent vs. 0.0 percent). The most commonly reported adverse events with Allegra 180 mg and placebo, respectively, in SAR patients 12 years and older are headache (10.6 percent vs. 7.5 percent), upper respiratory tract infection (3.2 percent vs.3.1 percent), and back pain (2.8 percent vs. 1.4 percent). The most commonly reported adverse events in pediatric SAR patients aged 6 to 11 years with Allegra 30-mg tablets and placebo, respectively, are headache (7.2 percent vs. 6.6 percent), accidental injury (2.9 percent vs. 1.3 percent), coughing (3.8 percent vs. 1.3 percent), and upper respiratory tract infection (4.3 percent vs. 1.7 percent). Seasonal allergic rhinitis (SAR) is a chronic condition occurring during the spring and fall allergy seasons that is caused by the body's reaction to allergens that enter through the respiratory tract. Allergies affect as many as 40 million people in the United States -- 10 percent of children and 20-30 percent of adolescents suffer from allergies. Typical allergens that cause SAR are grass, tree, and weed pollens. Symptoms typically affect the nose, but patients also report itchy, watery eyes, sneezing and nasal congestion. SAR often remains undiagnosed and untreated because people mistake their symptoms as related to a "cold" or the "flu." Chronic idiopathic urticaria (CIU), is caused by a reaction to an unknown trigger in the upper layers of the skin. Its primary symptom is the formation of itchy hives that last less than 24 hours but can recur frequently for six weeks or longer. The cause of CIU cannot be discovered in at least 75 percent of cases. Aventis Pharmaceuticals is the U.S. pharmaceutical company of Aventis S.A., one of the world's leading life sciences companies. On a global basis, Aventis Pharma AG is dedicated to treating and preventing human disease through the discovery, development, manufacture and sale of innovative pharmaceutical products aimed at fulfilling unmet medical needs. Aventis Pharmaceuticals focuses its activities on important therapeutic areas such as cardiology, oncology, anti-infectives, arthritis, allergy and respiratory, diabetes and the central nervous system. The corporate headquarters of Aventis Pharma is in Frankfurt, Germany. The company's North America Commercial headquarters is in Parsippany, N.J. Closely aligned with Aventis Pharma are Aventis Pasteur, a world leader in vaccines based in Lyon, France, and Aventis Behring, a world leader in therapeutic vaccines with corporate headquarters in King of Prussia, Pennsylvania, USA. Aventis S.A. was launched in December 1999 through the merger of Hoechst AG and Rhone-Poulenc SA. Related Links: Allegra (fexofenadine HCl) and Aventis Pharmaceuticals. --------------------------------------------------------------------------------------------- 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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