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FDA Approves ASMANEX (R) TWISTHALER(R) (Mometasone Furoate Inhalation Powder) for the Once Daily Maintenance Treatment of Asthma in Children Ages 4-11
Date:2/4/2008

c use is based in part on results from a 12-week placebo-controlled trial of 296 patients 4 to 11 years of age who had been diagnosed with asthma for at least six months. Results showed significant improvement in percent predicted FEV1 (forced expiratory volume in one second) in patients treated with ASMANEX 110 mcg once-daily, in the evening, compared to placebo. In this study, secondary endpoints of morning and evening peak expiratory flow and rescue medication use were supportive of the efficacy of ASMANEX TWISTHALER.(4) The only recommended dose for children 4-11 is 110 mcg (1 puff) administered once daily in the evening.

About Pediatric Asthma

Asthma is a chronic disorder characterized by inflammation of the air passages, resulting in the temporary narrowing of the airways that transport air from the nose and mouth to the lungs.(1)(5) Asthma symptoms, such as coughing, wheezing, and shortness of breath, occur during the day and night, impacting multiple aspects of patients' lives.(5) Daytime symptoms can affect activities such as exercising or going to school.(6) Nighttime symptoms interfere with patients' ability to sleep.(7) Asthma affects more than one in every 20 children, and it is the third leading cause of hospitalization among children under the age of 15.(1)(8) It is also the most common cause of school absenteeism due to chronic disease, and it accounts for an annual loss of more than 14 million school days per year.(1) The estimated cost of treating asthma in those younger than 18 years of age is $3.2 billion per year.(9)

About ASMANEX(4)

ASMANEX was discovered and developed by Schering-Plough Research Institute and is currently approved for asthma treatment in more than 40 countries. ASMANEX offers an effective inhaled corticosteroid to help manage asthma symptoms in a device that was awarded the DuPont Award for innovation in packaging. The ASMANEX TWISTHALER employs an inhalation-driven device that does not use a propel
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SOURCE Schering-Plough Corporation
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