Glaxo Wellcome Submits New Drug Application for Asthma Drug Advair Diskus salmeterol/fluticasone propionate inhalation powder.RESEARCH TRIANGLE PARK Research Triangle Park, research, business, medical, and educational complex situated in central North Carolina. It has an area of 6,900 acres (2,795 hectares) and is 8 × 2 mi (13 × 3 km) in size. Named for the triangle formed by Duke Univ. , N.C.--(BUSINESS WIRE)--March 26, 1999-- A New Drug Application for the investigational asthma product, salmeterol/fluticasone propionate propionate /pro·pi·o·nate/ (pro´pe-o-nat) any salt of propionic acid. pro·pi·o·nate n. A salt or ester of propionic acid. propionate any salt of propionic acid. inhalation powder, has been submitted to the Food and Drug Administration by Glaxo Wellcome Inc. The new combination product, ADVAIR(TM) DISKUS(R), combines the powder formulations of salmeterol xinafoate sal·me·ter·ol xi·naf·o·ate n. An inhalant powder used to treat and prevent bronchospasm in patients with asthma. salmeterol xinafoate (salmet´ , a long-acting inhaled bronchodilator bronchodilator /bron·cho·di·la·tor/ (-di´la-ter) 1. expanding the lumina of the air passages of the lungs. 2. an agent which causes dilatation of the bronchi. , and fluticasone propionate, an inhaled corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and , in a single Diskus inhaler inhaler /in·hal·er/ (in-hal´er) 1. an apparatus for administering vapor or volatilized medications by inhalation. 2. ventilator (2). in·hal·er n. device. Asthma is a chronic disease characterized by bronchoconstriction and inflammation of the airways in the lungs. Long-acting bronchodilators Bronchodilators Definition Bronchodilators are medicines that help open the bronchial tubes (airways) of the lungs, allowing more air to flow through them. are often used in conjunction with inhaled corticosteroids for maintenance treatment of the bronchoconstriction and airway inflammation, respectively, that are associated with asthma. Advair Diskus is the first product to combine a long-acting bronchodilator and inhaled corticosteroid into one formulation. Clinical trials with Advair Diskus involved 1,824 adolescent and adult patients (12 years of age and older). Studies compared Advair Diskus with its individual components, salmeterol or fluticasone propionate, or with the two agents administered concurrently by separate inhalers. Each of the studies used one of the three dosage strengths of Advair Diskus, which contain 50 mcg of salmeterol per inhalation and either 100, 250 or 500 mcg of fluticasone propionate per inhalation. All doses were given by one inhalation from the Diskus device twice daily. The Centers for Disease Control estimate that more than 15 million Americans have asthma. Asthma accounts for more than 450,000 hospitalizations, 1.9 million emergency room visits and 5,000 deaths each year. Advair Diskus is formulated as a dry powder medication and is administered via the Diskus inhaler, a breath-activated device. The combination product is currently available in the U.K. and Sweden, where it is known as Seretide. Glaxo Wellcome also developed and markets Flovent(R) (fluticasone propionate) Inhalation Aerosol, Flovent(R) Rotadisk(R) (fluticasone propionate inhalation powder), Serevent(R) (salmeterol xinafoate) Inhalation Aerosol and Serevent(R) Diskus(R) (salmeterol xinafoate inhalation powder). |
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