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Eurand's Zentase Effective in Treating Exocrine Pancreatic,Insufficiency, Studies Show

EPI patients in the pivotal study, regardless of disease severity, experienced a clinically significant response to Zentase treatment. Half of these patients had a CFA greater than 90 percent following Zentase treatment and 90 percent of patients had a CFA greater than 79 percent following Zentase treatment. Based on these study findings, Zentase may able to treat all patient types, from those requiring low levels of supplementation to those with severe disease needing high levels of enzyme supplementation.

Pivotal Study Highlights

This randomized, double-blind, placebo-controlled, cross-over study was conducted in 14 CF centers in the US and involved data from 31 patients with EPI. The average age was 15.4 years and the study was evenly split between male and female patients. After open-label dose titration, patients were randomized to receive Zentase or placebo over a week-long period. Following open-label normalization, all patients were crossed over to the alternative treatment arm. A determination of CFA and CNA on a 72-hour sample and under controlled diet in a hospital environment was performed at the end of each randomized treatment arm. No drugs affecting GI motility or pH (eg, PPIs or H2 blockers) were allowed under Zentase treatment.

    -- Direct Dose Response on Improving EPI Symptoms.  Increasing the Zentase

       dose displayed a direct correlation on improving EPI symptoms including

       stool consistency and symptom scores including measures of pain,

       bloating, gas and oil visibility.  A mean increase of 40 percent from

       first to last dose changed the majority of patients from highly

       symptomatic to normal. This was particularly notable for patients with

       abnormal stool at baseline.

    -- Improved Malabsorption Symptoms in Severe EPI Patients.  Response to

       Zentase correlated very well (r> 0.9) with disease severity. Patients

       with more severe malabsorption on placebo (CFA<60 
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