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 -
June 25, 2008 - Mpex Pharmaceuticals, Inc. announced that it has initiated a Phase 2 clinical study with MP-376 for the treatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis. MP-376 is Mpex's proprietary aerosol formulation of levofloxacin, an antibiotic that has potent activity against key bacterial pathogens, including Pseudomonas aeruginosa. Delivery of levofloxacin directly to the lungs of CF patients by the aerosol route can potentially provide a number of safety and efficacy advantages compared to oral or IV administration.
MP-376 is delivered using a customized configuration of PARI's highly efficient eFlow® electronic nebulizer... Mpex Pharmaceuticals' Press Release -
