Schering-Plough Corporation has announced that the FDA has approved ASMANEX® TWISTHALER® 110 mcg (mometasone furoate inhalation powder) for the maintenance treatment of asthma as a preventive therapy in patients 4 to 11 years of age. ASMANEX is an inhaled corticosteroid (ICS). ASMANEX 220 mcg was approved on March 31, 2005 by the FDA for maintenance treatment of asthma as preventive therapy in patients 12 years of age and older. Asthma is the most common chronic condition among children, and it is the cause of almost three million physician visits and 200,000 hospitalizations among children each year. Taken every day, maintenance inhalers help prevent asthma symptoms. “As the first inhaled corticosteroid that is approved for once-daily dosing in children as young as age four, the approval of the pediatric indication for ASMANEX provides an important treatment option for children with moderate and mild persistent asthma,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. According to updated guidelines from the National Asthma Education and Prevention Program, inhaled corticosteroids are the preferred foundation therapy for initiating long-term control in children with persistent asthma. Continual use of ASMANEX helps manage asthma symptoms in patients with persistent asthma. Additionally, its automatic dose counter helps patients track remaining doses. The FDA approval of ASMANEX for pediatric 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. The only recommended dose for children 4-11 is 110 mcg (1 puff) administered once daily in the evening.