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| |  Merck's Investigational Asthma Drug May Alleviate Widespread Problems SAN FRANCISCO, May 20, 1997 -- Clinical studies being presented this week show that Singulair(R) (montelukast sodium), an investigational oral asthma medicine, may provide new approaches to the serious problems affecting many of America's 14 million asthma sufferers. Research presented at the American Lung Association/American Thoracic Society International Conference demonstrates that Singulair, which was administered in clinical studies as a tablet once a day (10 mg/adult, 5 mg chewable/pediatric), significantly improved chronic symptoms and measurements of airway obstruction, and enhanced asthma-specific quality of life for a broad range of asthma patients, both adults and children (ages six and above). A leukotriene receptor antagonist, Singulair was discovered and is being developed by Merck & Co., Inc. Singulair is the most recently developed anti-asthma compound in the leukotriene receptor antagonist class. The drug works by blocking leukotrienes (pro-inflammatory mediators of asthma). It has been studied for the long-term control of asthma, but not for the treatment of acute asthma attacks. Seeking a new way to treat asthma "Singulair is the result of two decades of pioneering asthma research undertaken at the Merck Frosst Research Laboratories in Montreal, Canada, during which Merck studied and rejected many earlier investigational medicines," said Beth Seidenberg, M.D., Executive Director, Clinical Research, Merck Research Laboratories. "Results being presented this week demonstrate new advances being made in leukotriene research, which are providing patients with novel and important therapeutic alternatives for asthma." Clinical study results presented Following are results from five studies presented this week at the American Lung Association/American Thoracic Society International Conference: Singulair, a CysLT1 receptor antagonist, improves asthma outcomes over a three-month treatment period -- In a three-month study of 681 adult chronic asthmatics, Singulair (10 mg) given once daily increased the number of asthma-free days by 37 percent and decreased days with worsening asthma by 31 percent as compared to placebo. Singulair improves asthma over a two-month treatment period in six- to 14-year-olds -- Pediatric patients with chronic asthma (ages six to 14) received Singulair (5 mg chewable) or placebo once a day for eight weeks. Approximately 40 percent of these 336 patients also received inhaled corticosteroids. Singulair, compared with placebo, caused significant improvements in breathing measurements (including FEV1, or Forced Expiratory Volume in one second), decreased the need for beta-agonists and improved pediatric asthma-specific quality of life measurements (symptoms, activity and emotion). Daytime symptoms were improved with Singulair as compared to placebo, but the difference did not reach statistical significance. Singulair allows tapering of inhaled corticosteroids in asthmatic patients while maintaining clinical stability Effect of Singulair on airway eosinophilic inflammation in mildly uncontrolled asthma -- In a four-week study of 40 adult asthmatics, Singulair (10 mg) significantly reduced airway and blood eosinophils compared to placebo. Eosinophils are important pro-inflammatory cells in asthma. In these studies, Singulair was generally well tolerated. Adverse experiences were generally transient and limited. The most frequently reported events (whether or not drug related) were headache, gastrointestinal disturbances and upper respiratory infections. Asthma severity rising despite array of treatment options Despite the climate of health awareness and an array of treatment options, asthma incidence and severity is on the rise. The National Center for Health Statistics estimates that between 1990 and 1994, the incidence of self-reported asthma in the U.S. increased from 10.4 million to 14.6 million. The disease affected an estimated 4.8 million children under the age of 18 in 1994; it is the leading cause of school absenteeism attributed to chronic conditions, and the leading cause of hospitalization for chronic illness among children under 15. Because the most commonly prescribed asthma medications must be inhaled, patients -- particularly children -- often have difficulty using them, making lack of compliance a key issue associated with the management of this disease. The role of leukotrienes in asthma Cysteinal leukotrienes affect a number of abnormalities associated with asthma, including airway functions and inflammation. Singulair acts as a specific blocker of the leukotriene receptor, known as the CysLT1 receptor. Studies show that by blocking the effects of the cysteinal leukotrienes, Singulair improves the signs, symptoms, and parameters associated with asthma. Merck has filed a New Drug Application for Singulair with the U.S. Food and Drug Administration. Merck & Co., Inc. is a leading research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human health.
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