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PARI Pharma Completes Successful Clinical Trials for Tobramycin 100 & Investigational eFlow for CF
Date:11/10/2008

inhalation of PARI Tobramycin 100 versus TOBI in 86 cystic fibrosis patients. The study was conducted in several CF centers in Germany and Poland. The primary endpoint was the maximum tobramycin serum level (Cmax) as safety surrogate parameter at day seven. The PARI Tobramycin 100 Cmax level for the overall, adult and non-adult population was 1.29, 1.21 and 1.36 mg/L, compared to 1.65, 1.81 and 1.52 mg/L, respectively, for the TOBI group. Based on a 30% margin and 90% confidence intervals, PARI Tobramycin 100 achieved non-inferiority in the overall, adult and children population (p < 0.001 to 0.02). All Cmax values were well below recommended safety thresholds for systemic and inhaled tobramycin applications. Tobramycin sputum concentrations were similar and the adverse reaction rate after 28 days of tobramycin inhalation was comparable for both treatment regimes. There was a marked reduction in the mean inhalation time from 16.0 min for TOBI to 4.6 min for the PARI Tobramycin 100 application.

About PARI Tobramycin 100

PARI Tobramycin 100 is an investigational proprietary aqueous solution of 150mg tobramycin/1.5mL for inhalation delivery via a customized Investigational eFlow Nebulizer System, both developed by PARI Pharma, as a potential treatment for patients suffering from bacterial infections caused by Pseudomonas aeruginosa. Patents on both the drug formulation and device were granted in Europe and several other countries. Low volume/high concentration drug products such as PARI Tobramycin 100 delivered using eFlow Technology have shown to substantially shorten nebulized treatments and are believed to become a major relief in patients' lives.

About the Investigational eFlow Nebulizer System and eFlow Technology

The Investigational eFlow Nebulizer System uses eFlow Technology to enable highly efficient aerosolization of liquid medications via a vibrating, perforated membrane that includes thousands of small holes that produce the aer
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SOURCE PARI Pharma
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