Sep 15 2009
Mpex Pharmaceuticals, Inc. reported positive top line results from a Phase 2b clinical trial with Aeroquin, a novel aerosol formulation of levofloxacin delivered by an optimized Investigational eFlow Nebulizer System from PARI Pharma. In the Mpex cystic fibrosis trial, nebulized Aeroquin met the primary endpoint of reducing bacterial counts of Pseudomonas aeruginosa in sputum after 28 days of dosing versus placebo.
"It is exciting to see these positive results with Mpex's Aeroquin delivered by an optimized Investigational eFlow Nebulizer System. We are seeing a variety of studies showing great results when inhaled medications are optimized for delivery with a customized Investigational eFlow Nebulizer System. This is good news for cystic fibrosis patients and their care givers," said Martin Knoch, president of PARI Pharma Gmbh.
Mpex reported that clinically and statistically significant improvements versus placebo were also seen in a number of important clinical endpoints, including FEV1, % predicted FEV1, FEF25-75 (all measures of respiratory function) and time to need for anti-pseudomonal antibiotics (a measure of exacerbations). Aeroquin is a proprietary formulation of levofloxacin that has been optimized for aerosol delivery using a customized Investigational eFlow Nebulizer System. Levofloxacin is a fluoroquinolone antibiotic that has been widely used in a variety of indications for over a decade and has established safety and efficacy when administered orally or intravenously against many bacterial pathogens, including P. aeruginosa. Administration of Aeroquin with a high efficiency nebulizer to the lungs allows for the rapid delivery of high concentrations of active drug directly to the site of infection, while minimizing systemic exposure. For more information on the Phase II trial and Aeroquin, please visit www.mpexpharma.com.
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