Phase 2b Trial Expected to Begin in the Second Quarter of 2008
SAN DIEGO, March 4 /PRNewswire/ -- Mpex Pharmaceuticals, Inc. today 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.
"Obtaining orphan drug designation for MP-376 in cystic fibrosis is an important milestone for the program," stated Daniel Burgess, President and Chief Executive Officer of Mpex Pharmaceuticals, Inc. "This helps reinforce our belief that MP-376 has the potential to provide a valuable new treatment option in the management of cystic fibrosis. We look forward to working with CF patients, treatment providers and the FDA to rapidly advance this product candidate through to commercialization."
Orphan status is granted by the FDA to promote the development of
products that demonstrate promise for the treatment of rare diseases
affecting fewer than 200,000 Americans annually. Orphan drug designation
will entitle Mpex to a seven-year period of exclusive marketing rights for
MP-376 for the orphan indication following the date of the drug
|SOURCE Mpex Pharmaceuticals, Inc.|
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