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| |  Zyflo Anti-Leukotriene Drug Cleared for Chronic Asthma ABBOTT PARK, Ill., Dec. 11, 1996 -- Zyflo (zileuton) has been cleared by the U.S. Food and Drug Administration (FDA) for the prevention and chronic treatment of asthma in patients aged 12 years and older. Zyflo, developed by Abbott Laboratories (NYSE: ABT), is a member of a new class of anti-leukotriene asthma medicines that acts as a leukotriene pathway inhibitor (LPI). HOW ZYFLO WORKS By inhibiting the enzyme 5-lipoxygenase (5-LO), Zyflo inhibits the formation of leukotrienes. Leukotrienes contribute to the inflammation, swelling (edema), bronchoconstriction (tightening of muscles wrapped around the outside of the airways) and mucus secretion seen in the airways of patients with asthma. "Zyflo offers asthma patients a new treatment option to enhance control of their asthma," says Andre Pernet, Ph.D., vice president of pharmaceutical products research and development at Abbott Laboratories. "By inhibiting formation of leukotrienes, Zyflo helps control asthma symptoms." ZYFLO IMPROVES AIRWAY FUNCTION WHILE REDUCING CONCURRENT MEDICATION USE In clinical trials involving patients with mild-to-moderate asthma who used daily inhaled beta-agonists, Zyflo decreased the percentage of patients requiring steroid rescues for worsening asthma compared to patients treated with placebo. Overall, the percentage of Zyflo patients requiring steroid rescue was 7 percent, compared with 18.7 percent of patients in the placebo group. This represents a reduction of 62 percent. In addition, patients receiving Zyflo also were able to reduce their use of inhaled beta-agonists. At the end of the six-month study, the number of beta-agonist puffs needed per day was 1.77 puffs or 31 percent lower than baseline in Zyflo-treated patients; there was a 0.22 puff decrease in the placebo group. The reduction in the use of these medications was accompanied by improvements in lung function. Patients' asthma symptoms also were improved when compared to baseline measurements. Daytime symptoms improved by 36 percent, and night-time symptoms improved 31 percent in patients treated with Zyflo. For placebo-treated patients, improvements were 21 percent and 5 percent respectively. "We've waited a long time for new treatment options for patients with asthma," says Jeffrey Drazen, M.D., Parker B. Francis professor of medicine, Harvard Medical School. "Fewer patients receiving zileuton (Zyflo) needed steroid rescues. In addition, patients taking zileuton required less inhaled beta-agonist medication. At the same time, the patients' lung function improved and they had fewer symptoms." ZYFLO IS WELL-TOLERATED Zyflo should not be used to treat acute episodes of asthma. Safety data with Zyflo have been gathered from more than 5,500 patients. In asthma studies, the overall incidence of adverse events was similar between the Zyflo- and placebo-treated groups. Dyspepsia (upset stomach) occurred significantly more often among patients treated with Zyflo than with placebo. Some patients treated with Zyflo experienced elevations in liver function tests. Patients taking Zyflo should have their liver function tested prior to taking, and periodically while taking the medication. Zyflo should not be taken by patients who have active liver disease or liver enzymes that are elevated. Although liver function test elevations were observed throughout the treatment period, the majority of these elevations developed during the first two months of treatment. Generally, these abnormalities resolved or decreased to acceptable levels while treatment continued or soon after it was stopped. Doses of theophylline, warfarin, and/or propranolol should be adjusted and patients monitored when taking Zyflo. The recommended dosage of Zyflo is one 600 mg tablet four times daily. Zyflo will be available nationwide by prescription in January. Approximately one in 20 Americans has asthma. The symptoms of asthma include wheezing, coughing and shortness of breath. From 1982-1992, the annual prevalence of self-reported asthma increased 42 percent. In 1990, health care expenditures for asthma were estimated to be $6.2 billion, or about 1 percent of all U.S. health care costs. Abbott Laboratories is a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company employs 52,000 people and markets its products in more than 130 countries. In 1995, the company's sales and net earnings were $10.0 billion and $1.7 billion, respectively, with earnings per share of $2.12.
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