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| |  Design Helps Make Asthma Control Easier RESEARCH TRIANGLE PARK, N.C. -- September 23 -- The U.S. Food and Drug Administration (FDA) has cleared for marketing Serevent(R) Diskus(R) (salmeterol xinafoate inhalation powder), which contains a powder formulation of salmeterol in a new, delivery device that helps ensure consistent medication delivery with every dose. Serevent Diskus offers patients similar preventive benefits as Serevent Inhalation Aerosol, the first and only long-acting inhaled bronchodilator that provides long-term control over asthma symptoms. "Delivery of medication to a patient's lungs is a key factor in controlling asthma symptoms," said Kathleen Rickard, M.D., director of Respiratory U.S. Medical Affairs for Glaxo Wellcome. "Patients may find Serevent Diskus easy to use because they do not have to coordinate activating the device with inhalation, as patients do with traditional metered-dose inhalers. This may be particularly helpful for elderly patients and those who have difficulty using other inhalers." For maintenance therapy of asthma, patients should take one inhalation (50 mcg) twice daily (morning and evening), approximately 12 hours apart. Serevent Diskus encourages compliance with a built-in dose counter that displays how many doses are remaining in the medication. Reminding patients when the medication needs to be refilled, the display highlights the last five doses in red. To take the medication, patients must simply rotate the delivery device, which automatically prepares one unit dose to be released, and then inhale the dose. Medication compliance is a serious health issue. Studies show between 30 to 70 percent of patients with asthma fail to comply with their doctors' instructions about medication and approximately 125,000 patients with treatable diseases die every year from treatment noncompliance. However, research shows simplifying the treatment regimens for chronic disease sufferers can result in improved compliance and better treatment outcomes. Serevent Diskus is indicated for maintenance treatment of asthma and prevention of bronchospasm in patients 12 years and older with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma who require regular treatment with inhaled, short-acting beta-2 agonists. Serevent Diskus is not a substitute for fast-acting bronchodilators, which treat sudden asthma symptoms, and should never be taken more than twice a day. It is a preventive medication that takes longer to be effective. So when sudden symptoms occur, patients still need a fast-acting bronchodilator prescribed by their doctor. The product also is not a substitute for medication that controls inflammation in the lungs. It can be used with or without an anti-inflammatory asthma medication. Patients should not stop or change the dosage of their other asthma medications without talking to their doctor and if their condition worsens, patients should contact their doctor immediately. Asthma is a serious chronic disease that affects nearly 15 million people in the United States; if not properly managed, asthma can be life-threatening. The disease is characterized by a reversible obstruction of the bronchial airways of the lungs caused by inflammation and mucus in the airways and contraction of the muscles that surround the airways and airway swelling. The 1997 National Institutes of Health Guidelines for asthma management recognize the benefits of a long-acting beta-agonist like Serevent Diskus for long-term treatment of asthma and prevention of symptoms in patients with moderate persistent and severe persistent asthma. In clinical trials of Serevent Diskus, the most common drug-related side effects reported with a frequency of less than or equal to one percent were headache and tremor.
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