March 4, 2008 – Mpex Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration's (FDA) Office of Orphan Products Development has granted Mpex orphan drug designation for levofloxacin solution for inhalation for the treatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis. Levofloxacin is the active pharmaceutical ingredient in MP-376, the company’s proprietary levofloxacin solution for inhalation. Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa. Chronic pulmonary infections are difficult to eradicate and are implicated as the major cause of deterioration of pulmonary function and associated morbidity and mortality in CF patients. Chronic infection is associated with pulmonary exacerbations due to bacterial overgrowth, and a decrease in lung function over time from inflammation triggered by bacteria and their toxins... Mpex Pharmaceuticals' Press Release -
