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| |  Tilade Nebulizer Cleared By FDA COLLEGEVILLE, PA -- November 17, 1997 –The U.S. Food and Drug Administration (FDA) has granted marketing clearance to Rhone-Poulenc Rorer Inc.’s Tilade(R) Nebulizer Solution (nedocromil sodium inhalation solution) as therapy for mild to moderate asthma in patients two years of age and older. Tilade Nebulizer Solution is a new dosage form of RPR's Tilade Inhaler, an inhaled non-steroidal anti-inflammatory agent for the preventive management of mild to moderate asthma. A nebulizer is a device used to reduce liquid medication to fine particles so that it can be delivered by inhalation to the respiratory tract. "The new nebulizer solution, available in early 1998, will be of particular benefit to those asthma sufferers who have difficulty using a metered-dose inhaler, particularly children and the elderly," said Dr. Gary Shearman, senior vice president of drug development at RPR. Patients should use the Tilade Nebulizer Solution at regular intervals in order to achieve maximum benefit. Symptomatic improvement may occur within the first few days of treatment, full benefit may be achieved in two to four weeks or longer. The safety and efficacy of Tilade Nebulizer Solution was studied in eight randomized, double-blind, parallel, placebo-controlled U.S. clinical trials of 1,403 patients with mild to moderate asthma. Patients treated with Tilade Nebulizer Solution experienced statistically-significant reductions in asthma symptoms and a greater increase in morning peak expiratory flow rates versus placebo. The most common adverse events from all eight clinical trials reported more frequently for those receiving Tilade Nebulizer Solution versus placebo were sore throat, sinusitis and fever. Asthma is a chronic inflammatory condition that affects more than 10-12 million Americans, including nearly five million children.
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