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PARI Pharma Receives 2nd ODD From EMEA; Moves Inhaled Tobramycin - eFlow Technology Program Forward
Date:5/7/2009

stigational eFlow Nebulizer System versus TOBI/LC PLUS in 16 cystic fibrosis patients, including 8 adults and 8 children. Tobramycin lung deposition for both applications was between 46mg and 47mg. Results from the study will be presented at the European Cystic Fibrosis Conference (ECFC) in June 2009.

In addition, a Phase II multicenter clinical trial (10 sites) assessed safety and tolerability of PARI Tobramycin 100 (150mg/1.5mL) administered via an Investigational eFlow Nebulizer System in comparison to TOBI (tobramycin 300mg/5mL) delivered via the PARI LC PLUS. 78 patients suffering from cystic fibrosis (36 adults and 42 children) inhaled the study medication for 28 days in a parallel study design.

While key deposition and safety thresholds were maintained, the marked difference was a reduction in the average inhalation time to 4 - 4 1/2 minutes for the PARI Tobramycin 100, down from 16 - 17 minutes for the TOBI therapy, a 73% reduction in treatment time. Results for both formulations show no difference in the ratio of peripheral to central lung deposition. Maximum tobramycin serum levels were below recommended safety thresholds for systemic and inhaled tobramycin applications. Although tobramycin sputum concentrations were slightly higher in the T100 cohort, plasma levels and adverse reaction rates were slightly, but not significantly, lower being regarded as desirable. It appears that, for a twice-daily treatment with PARI Tobramycin 100 delivered via an Investigational eFlow Nebulizer System, approximately 10+ hours of inhalation time per month can be saved compared to TOBI.

About PARI Tobramycin 100

PARI Tobramycin 100 is an investigational proprietary aqueous solution of 150mg tobramycin/1.5mL for inhalation delivery via an optimized Investigational eFlow Nebulizer System, both developed by PARI Pharma, as a potential treatment for patients suffering from bacterial infections caused by '/>"/>

SOURCE PARI Pharma
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