To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ALLEGRA New Non-Sedating Antihistamine Now Available URL: http://www.pslgroup.com/dg/9F42.htm Doctor's Guide August 20, 1996
KANSAS CITY, Mo., Aug. 20, 1996 -- Hoechst Marion Roussel announced today that ALLEGRA(TM) (fexofenadine hydrochloride), a nonsedating antihistamine, is now available by prescription. ALLEGRA offers safe, effective relief of seasonal allergy symptoms -- as early as one hour. Its continual effectiveness throughout the dosing period, coupled with the fact that the same dosage can be used for most patients, makes ALLEGRA a potential treatment option for all seasonal allergy sufferers aged 12 and over. ALLEGRA was cleared for marketing by the U.S. Food and Drug Administration (FDA) for relief of seasonal allergic rhinitis on July 25, 1996. "Allergy sufferers now have more treatment options available than ever before. ALLEGRA appears to be a safe medication that reduces the seasonal allergy symptoms of sneezing, runny nose and nasal and eye itching," said Michael A. Kaliner, M.D., medical director, Institute for Asthma and Allergy, Washington, D.C. "It is a nonsedating antihistamine that may appeal to allergy sufferers and help to keep their symptoms from interfering with their day-to-day activities." The labeling of ALLEGRA recommends dosing of one 60-mg capsule, twice daily (bid). The recommended starting dose for patients with decreased kidney function is 60 mg, once daily. The onset of action for ALLEGRA was observed at one hour in a controlled clinical trial. Additional studies demonstrated that allergy sufferers continued feeling relief throughout the 12-hour dosing period. Also, two-week trials showed that ALLEGRA provided significant symptom relief throughout the full course of therapy. ALLEGRA was shown effective in a trial where allergy sufferers were exposed for five hours to extremely high pollen challenges in a pollen chamber. This exposure may have been much greater than what some patients would experience in a "very high" pollen season. Unlike some other antihistamines currently available, ALLEGRA requires negligible liver metabolism. Safety in Relief Clinical trials have demonstrated significant relief without sedating side effects. In clinical trials of more than 2,000 allergy sufferers, the incidence of adverse effects reported with ALLEGRA was similar to placebo. ALLEGRA studies have found no significant drug interactions with the macrolide antibiotic erythromycin and the antifungal ketoconazole. These agents have been known to interact with some other antihistamines. In addition, cardiac side effects reported were similar to placebo. The most commonly reported adverse experiences for ALLEGRA and placebo are 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). ALLEGRA is available by prescription only. ALLEGRA is priced 15 percent lower than similar treatments. Allergy sufferers should consult their physician or health professional with questions. Rapid Development and Approval Hoechst Marion Roussel, formerly Marion Merrell Dow Inc., was the originator of nonsedating allergy relief. ALLEGRA was identified as a metabolite of terfenadine. That is, fexofenadine is a compound derived from terfenadine, but has unique chemical and pharmacological properties of its own. ALLEGRA blocks histamine without crossing the blood-brain barrier, as shown in in vitro studies. ALLEGRA demonstrated significant antiallergy benefits which warranted further development. The development and submission of ALLEGRA to the FDA was completed in only 2.8 years, compared to the industry average of 14 years. "Despite the rapid process, ALLEGRA has been comprehensively tested under the newest and most rigorous parameters in evaluating its effectiveness as a seasonal rhinitis treatment," said Dennis Giesing, Ph.D., fexofenadine global team leader, Hoechst Marion Roussel. "We are thrilled to bring ALLEGRA to allergy sufferers. We are confident that ALLEGRA is a safe and effective treatment that a seasonal allergy sufferer can take for relief," said Kirk Schueler, vice president, U.S. commercial director, Hoechst Marion Roussel USA. "Since introducing nonsedating allergy treatment in the mid-1980s, Hoechst Marion Roussel has always been striving to improve the treatment options available to allergy sufferers. ALLEGRA represents our efforts to bring allergy treatment into the next era." What is Seasonal Allergic Rhinitis (SAR)? Seasonal allergic rhinitis 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 respiratory and alimentary tracts and sometimes through the skin. According to the National Institute of Allergy and Infectious Diseases (NIAID), allergies affect as many as 50 million people. Typical allergens that cause SAR are grass and tree pollens, molds and ragweed pollen. Symptoms typically affect the nose, but patients also report itchy, watery eyes and inflammation of the sinuses or ears. Seasonal allergic rhinitis often remains undiagnosed and untreated because people mistake their symptoms as related to a cold or the flu. Hoechst Marion Roussel, the pioneer in nonsedating allergy treatment, is dedicated to extending and enhancing human life through the discovery, development, manufacture and sale of pharmaceutical products. Hoechst Marion Roussel, with global headquarters in Frankfurt, Germany, and North American headquarters in Kansas City, Mo., is a member of the Hoechst Group. --------------------------------------------------------------------------------------------- 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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