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| |  FDA Approves Singulair (Montelukast Sodium) For Asthmatics As Young As Two Years WEST POINT, PA -- March 6, 2000 -- Ask parents about the daily concern of caring for their very young children with asthma. It isn't easy. Asthma afflicts approximately five million American children and an estimated 1.3 million children under age five, making it the most common chronic illness of childhood.(1) But today the parents of children ages two to five years with asthma have a new treatment option that is a once-a-day medicine and is not a steroid. The U.S. Food and Drug Administration (FDA) has approved Singulair(R) (montelukast sodium) 4 mg tablets for the prevention and chronic treatment of asthma in children aged two to five. Currently, few options exist to treat asthma in this age group. Singulair is the first asthma controller therapy in more than 15 years indicated for children as young as two. Singulair 4 mg comes in a convenient cherry-flavored chewable tablet. Singulair was approved in February 1998 as a 5 mg cherry-flavored chewable tablet for children ages 6 to 14 and as a 10 mg tablet for adolescents and adults 15 and older for the prevention and chronic treatment of asthma. In clinical studies in these patients, side effects seen with Singulair were generally similar to placebo, or a sugar pill. The most commonly reported side effects in adults were headache, influenza and abdominal pain. The new 4 mg tablet strength extends the use of Singulair to patients as young as two and will be available in pharmacies by mid-March. "If you've ever heard a young child say, 'I can't breathe,' you have some idea of the anguish and frustration felt by the parents of youngsters with asthma," says Donna Bratton, M.D., associate professor, National Jewish Medical and Research Center, Denver. "Treatment regimens for children ages two to five who have asthma may require the child to cooperate while medicine is administered through a breathing device called a nebulizer," Bratton said. Since April 1999, Singulair has been the most prescribed controller agent by allergists and the second most prescribed controller agent by pediatricians, based on total prescriptions.(2) Since approval in February 1998, Singulair 5 mg and 10 mg have been prescribed to more than 1.5 million patients in the United States, the most successful launch ever for an asthma controller medicine.(3) Singulair should not be used for the immediate relief of asthma attacks or to prevent or treat asthma made worse by exercise. Patients who have asthma made worse by exercise should continue to use their existing medications prior to exercise, unless instructed otherwise by their doctor. The use of Singulair may not eliminate the need for inhaled or oral corticosteroids. Patients should not decrease the dose or stop taking other asthma medications unless instructed by their doctor. Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking Singulair. Long-term studies evaluating the effect of chronic administration of Singulair on linear growth, i.e. height, in pediatric patients have not been conducted. Singulair should be taken once daily in the evening. Singulair 4 mg, a member of the leukotriene-antagonist class of asthma medicines, is the first once-a-day, non-steroid chewable tablet approved for use for children ages two to five for the prevention and chronic treatment of asthma. In clinical studies of patients in this age group, Singulair had a side effect profile similar to that seen in patients 6 to 14 years of age. Efficacy of Singulair in pediatric patients ages two to five years is based on extrapolation of the demonstrated efficacy in adolescents and adults 15 years and older and in patients 6 to 14 years of age with asthma. Singulair works by blocking leukotrienes, which are naturally occurring substances in the lungs. With asthma, the amount of leukotrienes increases when a person is exposed to certain irritants. This contributes to inflammation and narrowing of airways, which makes it difficult to breathe. "Until now Singulair was only indicated for adults and children as young as six," adds Barbara Knorr, M.D., senior director, Merck Research Laboratories. "The availability of Singulair in a chewable 4 mg pill for children aged two to five with asthma gives these children a new therapeutic option." Safety data for Singulair 4 mg chewable tablet in two to five year olds were obtained from an interim analysis of 314 pediatric patients from a 12-week, double-blind, placebo-controlled clinical study of approximately 650 patients. Of the 314 patients, 212 received Singulair 4 mg and 102 received placebo (a sugar pill) over at least six weeks of therapy. Patients in the study had a history of physician-diagnosed asthma with at least three episodes (such as coughing, wheezing and shortness of breath) within the year prior to the study. The safety profile of Singulair in this interim analysis of patients ages two to five who received Singulair for at least six weeks was generally similar to the safety profile seen in older pediatric patients 6 to 14 years of age. The most common side effects included runny nose, ear infection, ear pain and rash. Asthma is the most common chronic illness of childhood, afflicting approximately five million American children. Between 1980 and 1994, self- reported asthma increased by 160 percent among children age four and under.(4) The estimated annual cost of treating asthma in children under 18 years of age is $3.2 billion and the estimated rate for emergency room visits among children under age five is the highest of all age groups.(5) Childhood asthma accounts for more than 10 million days missed from school annually, making it the most common cause of school absences from chronic disease in the United States.(6) Notes:
Related Link: Merck.
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