Eurand Announces Positive Phase III Clinical Study Results ( ars) and an olderpatient population. ...)

Eurand Announces Positive Phase III Clinical Study Results

ars) and an older patient population.

Study results showed a clinically and statistically significant increase in the coefficient of fat absorption (CFA) in patients treated with Zentase. The mean percentage of CFA in patients receiving Zentase was 88.3 percent versus 62.8 percent in patients receiving placebo (p<0.001). Treatment guidelines suggest that the CFA should be at least 85 percent in cystic fibrosis (CF) patients(3).

"The protocols for these trials were reviewed by the FDA and developed in collaboration with the Cystic Fibrosis Foundation (CFF). We want to thank the CFF for their support," added Faherty.

Phase III Pivotal Study Results

This randomized, double-blind, placebo-controlled, cross-over study evaluated CF patients with EPI aged seven years and older. Patients treated with Zentase showed a statistically significant increase in the coefficient of fat absorption and coefficient of nitrogen absorption (CNA) as compared to those receiving a placebo. They also had fewer symptoms associated with impaired absorption such as bloating, flatulence, pain and evidence of fat in stools.

Moreover, in all study patients, regardless of starting levels while taking placebo, Zentase returned CFA and CNA absorption levels to ranges considered normal in healthy patients. We believe this suggests Zentase can provide the level of enzyme supplementation required by cystic fibrosis patients with different levels of EPI.

"I believe the results of this successful trial demonstrated the efficacy and safety of Zentase," said James E. Heubi, MD, Professor and Associate Chair for Clinical Research of Pediatrics at Children's Hospital Medical Center in Cincinnati, OH. "During the study, the level of fat absorption achieved with Zentase was very high and close to levels seen in healthy patients, even without the use of proton pump inhibitors (PPIs). This high fat absorption, without relying on PPIs could significantly reduce the number
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