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| |  FDA Approves Pulmicort Nebulized Corticosteroid (Budesonide) For Asthmatic Children WAYNE, PA -- August 9, 2000 -- AstraZeneca announced that its new asthma medication for young children and infants is now approved by the U.S. Food and Drug Administration. Known as Pulmicort Respules™ (budesonide inhalation suspension), the medication is the first and only asthma treatment approved for children and infants as young as 12 months. In addition, it is the first and only corticosteroid to be available as a nebulized formulation. Previously, inhaled corticosteroid therapy was only available for children four years of age and older and typically administered with an asthma inhaler which young children often are not able to use properly. Dr. Frank Casty, Executive Director, Respiratory and Inflammation, at AstraZeneca commented that Pulmicort Respules represents an innovative approach to corticosteroid delivery. "Now with the approval of Pulmicort Respules, physicians will have a way to administer inhaled corticosteroid therapy in infants and young children," said Dr. Casty. Pulmicort Respules is a preventative medication that helps control asthma in infants and children from 12 months to eight years of age. It is not a quick-relief medication (bronchodilator) and should not be used as the primary treatment during an asthma attack. Pulmicort Respules will be available by prescription in pharmacies in October. Asthma is the most common chronic pediatric disease. Its prevalence among children is increasing worldwide.(1) In the U.S., asthma affects nearly five million children (2) with as many as 80 percent demonstrating symptoms before the age of five.(3) "Prior to Pulmicort Respules, the anti-inflammatory treatment options for a young asthmatic child or infant were quite limited or non-existent," said David Skoner, MD, Chief of Allergy and Immunology at Children's Hospital of Pittsburgh. Current anti-inflammatory therapy for young patients unable to use asthma inhalers have involved bursts of oral steroids (e.g., tablets or syrup) and nebulized non-steroidal medications. Noted Dr. Skoner, "Pulmicort Respules marks a milestone in the treatment of persistent pediatric asthma. This is a serious inflammatory lung disease. The development of a corticosteroid treatment for infants and young children with asthma has been a medical imperative." The FDA approval of Pulmicort Respules is based on data from three 12-week double-blind U.S. clinical studies involving 946 children 12 months to eight years of age with mild to moderate persistent asthma. Pulmicort Respules reduced the need for bronchodilators and improved the control of nighttime and daytime asthma symptoms. In clinical studies, the most common side effects included respiratory infection, runny nose, coughing, earache, viral infection, stomachache, and ear infection and were not necessarily related to drug treatment. The incidence of side effects was similar to that seen with a non-medicated mist. Pulmicort Respules has been marketed around the world since 1990 and is now available in 55 countries. Its active compound, budesonide, has been used for over 15 years in various anti-asthma formulations worldwide. Pulmicort Turbuhaler® (budesonide inhalation powder) was launched by AstraZeneca as the first dry-powder, CFC-free corticosteroid inhaler in the U.S. in 1998. Asthma care guidelines developed by the U.S. National Institutes of Health (NIH) emphasize the importance of treating airway inflammation with inhaled corticosteroids. These medications are manmade versions of naturally occurring substances in the body that reduce swelling. The development of inhaled corticosteroids has allowed physicians the ability to target inflamed airways. The NIH's Expert Panel Report II on the Diagnosis and Management of Asthma considers inhaled corticosteroids to be the most effective therapy today for the control of persistent asthma. "The FDA approval of Pulmicort Respules is encouraging news for physicians, parents and their young children," said Dr. Skoner. "In my experience, this medication has dramatically improved asthma control in my young patients." Noted Dr. Skoner, "Asthma must be treated appropriately -- otherwise children may suffer the risks of life-threatening asthma attacks. Of course, children with asthma should be monitored when taking inhaled corticosteroids or any product that has pharmacologic activity. Then, the benefits and risks should always be assessed." Dosing with an inhaled corticosteroid should be reduced to the lowest amount necessary to maintain asthma control. If children are switched to Pulmicort Respules from an oral corticosteroid (syrup or tablet), they need to be carefully monitored by their physicians to avoid health risks associated with stopping the use of an oral corticosteroid. Nebulization is a popular way of delivering asthma medication to very young patients. Pulmicort Respules is the first corticosteroid approved for use in a device called a jet nebulizer, the most widely used type of nebulizer in the U.S. The jet nebulizer uses pressurized air to convert Pulmicort Respules, a water-based medication, into a fine mist. A young child then can inhale the mist through a face mask or a mouthpiece that is attached to the nebulizer. Pulmicort Respules is a fragrant-free, taste-free liquid packaged in a plastic container which a parent twists open and pours into a jet nebulizer cup. Pulmicort Respules may be taken once or twice daily. "This nebulized corticosteroid provides a practical and approved way for treating very young patients with persistent asthma," said Dr. Skoner. References: Related Link: AstraZeneca.
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