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| |  Azmacort Now Indicated as Prophylactic Therapy for Asthma COLLEGEVILLE, Pa., Nov. 4, 1996 -- Rhone-Poulenc Rorer Inc. (NYSE: RPR) announced today that the U.S. Food and Drug Administration (FDA) has granted clearance to market Azmacort(R) (triamcinolone acetonide) Inhalation Aerosol as a prophylactic therapy in the maintenance treatment of asthma with twice-daily dosing. Azmacort, the most widely prescribed inhaled bronchial steroid in the U.S., was previously indicated for patients who require chronic treatment for the control of bronchial asthma symptoms with a recommended dosage of two inhalations three to four times a day. The new prophylactic indication was received in conjunction with a recent class labeling change requested by the FDA. The only inhaled anti-inflammatory with a built-in spacer -- a device which extends the space between the opening of the metered-dose inhaler (MDI) and the patient's mouth -- Azmacort is designed to enhance therapy and compliance. The National Institutes of Health (NIH) recommends use of spacers, as they may reduce the potential for side effects in the mouth and throat and minimize coordination problems between actuation and inhalation. These factors can have a negative impact on patient compliance. "For more than 12 years, Azmacort has provided a safe and effective treatment option that many patients find easy to use," said Steve Connelly, RPR Senior Vice President and General Manager of The Americas. "These new indications build on that experience and offer patients a convenient twice-daily medication that can help them prevent asthma symptoms as well as treat chronic asthma," he added. The safety and efficacy of Azmacort given twice daily were demonstrated in two, six-week, placebo-controlled clinical trials involving 222 people with chronic asthma. Results of both studies demonstrated that treatment with Azmacort (400 mcg twice daily) resulted in significant improvement in lung function and asthma symptoms such as wheezing and cough, as well as a decrease in bronchodilator use. Bronchodilators are medications commonly used to "rescue" asthma patients once they feel an asthma attack is about to occur. In clinical trials with Azmacort, the most commonly reported side effects were pharyngitis, hoarseness, dry and irritated throat, and dry mouth. As with all inhaled bronchial steroids, adrenal insufficiency may occur when transferring patients from systemic steroids. Asthma is a chronic inflammatory condition that affects 12-15 million Americans -- including 4.8 million children -- and morbidity and mortality continue to rise. Asthma accounts for an estimated three million lost workdays annually, and is the number one cause of absenteeism from school and hospitalization among children. Rhone-Poulenc Rorer is a global pharmaceutical company dedicated to improving human health. In 1995, RPR had sales of $5.316 billion (pro forma) and invested $826 million (pro forma) in research and development.
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