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

percent) experienced significant improvements following Zentase treatment with a 43 percent median increase in CFA. -- Consistently Improved EPI Symptoms. Zentase treatment improved the signs and symptoms of malabsorption even in patients with CFA values greater than 80 percent under placebo. -- Well Tolerated. There were no unexpected or significant differences in adverse events (AEs) between treatment and placebo. No patient discontinued due to an AE. Two serious AEs were considered unrelated to study drug and resolved without discontinuation. The most commonly reported AEs for either group were abdominal pain, flatulence, abdominal distension, abnormal feces and steatorrhea.

Supportive Study Highlights

This open-label, multiple-dose, single-treatment study was conducted in 11 CF centers in the US and involved 19 CF patients with EPI. The average age was 3.9 years (range 1-6 years) with male patients accounting for 63 percent of the study participants. This was the first prospective study of PEPs involving children younger than 7 years of age. The study involved a seven- day dose stabilization period followed by a seven-day treatment period. Due to ethical concerns, placebo was not used and patients were switched from previous enzyme treatment without washout. No drugs affecting GI motility or pH (eg, PPIs or H2 blockers) were allowed under Zentase treatment.

    -- Provided Very Good Control of Symptoms to Patients.  The percentage of

       responders on Zentase, defined as having less than 30 percent fecal fat

       content and without signs and symptoms of malabsorption after 1 and 2

       weeks of treatment, was consistent with the percentage of responders

       under previous treatment (baseline).  In addition, Zentase treatment

       decreased stool frequency and oily stools vs baseline.  The mean number

       of stools per day was 
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