To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: New Singulair Paediatric Granules launched for Asthma Treatment in Children as Young as 6 Months URL: http://www.pslgroup.com/dg/2450CE.htm Doctor's Guide October 1, 2004
LONDON, UK -- October 1, 2004 -- Merck Sharp & Dohme Limited (MSD) announced today that it has launched Singulair® (montelukast) Paediatric 4mg Granules (Singulair® Granules), the first once-daily, non-steroidal, add-on asthma treatment for children as young as six months.1 Currently in the UK, there are limited treatment options to treat pre-school children with asthma. Singulair Granules are effective in treating asthma in 6 month to 5 year old patients as an add-on therapy.1 This novel formulation is child-friendly with no taste and can easily be mixed with soft foods for convenient administration.1 Professor David Price, University of Aberdeen commented, "Singulair Granules offer a unique and effective child-friendly treatment option for children as young as 6 months. Children should not be viewed as 'small adults' as they metabolise drugs differently, it is therefore encouraging that this medicine has been studied and developed with this specific age group in mind." The new child-friendly, granules formulation has been studied in clinical trials with infants aged 6 months to 24-months old,2 and has been shown to be an appropriate asthma therapy for this age group,1 adding to the existing formulations of Singulair for all ages.2 In a study, involving over 600 2- to 5-year-olds with mild to moderate asthma, montelukast 4mg was shown to improve symptom control from the first once-daily dose, significantly reducing the number of days with asthma symptoms. Compared with placebo, it demonstrated a 29% increase in the percentage of days without asthma. Breathing difficulties were reduced by 42%, episodes of wheeze by 39%, nighttime symptoms by 39% and cough by 35%.2 Singulair 4 mg has been proven to reduce the need for inhaled beta-agonist and oral corticosteroids for the treatment of acute asthma attacks.4 This is important in light of recent studies revealing that many patients are concerned about traditional asthma therapies, with a considerable number anxious about the long-term effects of corticosteroids.5 In addition, a number of studies have demonstrated that patient compliance (particularly among children) with inhaled treatments is generally low, averaging around 50%.1 The granules can be given alone or mixed with a spoonful of soft food such as applesauce, mashed carrots, rice or ice cream. These foods should be served cold or at room temperature. After opening the packet, the full dose must be given within 15 minutes and any leftovers must not be stored for future use. Oral granules should not be mixed in a liquid drink.1 Montelukast is generally well tolerated.3 Singulair Granules have been researched and licensed specifically for children in the 6 months to five year age group and has been shown to be effective in this age group.1 More than 1.4 million children have asthma in the UK, accounting for 14% of all hospital paediatric admissions and 5% of all primary care consultations for children.1 Merck Sharp & Dohme Limited (MSD) is the UK subsidiary of Merck & Co., Inc., of Whitehouse Station, New Jersey, U.S.A. Merck & Co., Inc. is a global research-driven pharmaceutical company that discovers, develops, manufactures and markets a broad range of innovative products to improve human health, directly and through its joint ventures. References 1. Singulair® Paediatric 4mg Granules - Summary of product characteristics. Merck Sharp & Dohme Limited, 2004. 2. Van Adelsberg J, Wei LX, Knorr B, Kuna P, Wildhaber J, Reiss TF. Montelukast oral granules improves asthma control in >/= 6- to <24-month old patients. Data on file, Merck Sharpe and Dohme Limited. 3. Singulair® - Summary of product characteristics. Merck Sharp & Dohme Limited, 2004. 4. Knorr B, Franchi LM, Bisgaard H et al. Montelukast, a leukotriene receptor antagonist, for the treatment of persistent asthma in children aged 2-5 years Paediatrics 2001; 108(3): 697-716. 5. Pediatric Asthma and Allergy & Immunology 1997; 11 (1):3-8. 6. National Asthma Campaign Asthma audit 2002. Starting as we mean to go on -- an audit of children's asthma in the UK. The Asthma Journal Suppl 2002;8:Issue 2. --------------------------------------------------------------------------------------------- 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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