(RTTNews) - Pharmaceutical company Eurand N.V. (EURX: News ), said Friday that data from its trial using Zenpep delayed release capsule in two dose regimen showed an improvement in fat absorption and body weight in patients with Exocrine Pancreatic Insufficiency as a result of chronic pancreatitis.

Amsterdam, the Netherlands-based Eurand noted that.Exocrine Pancreatic Insufficiency or EPI is a serious condition usually associated with a number of diseases including cystic fibrosis, chronic pancreatitis, pancreatic cancer, gastrointestinal surgery and other conditions. EPI can result in malnutition and negatively affect quality of life. Zenpep is a stable formulation of a porcine pancreatic extract that mimics the endogenous human pancreatic secretions necessary for proper human digestion.

The Phase II/III double-blind, randomized, dose-response control, crossover clinical Study repoted that two doses of Zenpep improved fat and protein absorption and, body weight of the patients with mild-to-moderate exocrine pancreatic insufficiency.

In patients with mild-to-moderate pancreatic disorder, lower dose of 35,000 lipase units per day of Zenpep resulted in coefficient of fat absorption of 88.9% and higher dose of 140,000 lipase units per day of Zenpep resulted in coefficient of fat absorption of 89.9%. Both lower as well as higher dose of the pancreatic enzyme product showed significant improvement in fat and protein absorption, the company said.

However, in patients with severe exocrine pancreatic insufficiency, higher dose was more effetive with coefficient of fat absorption of 84.1% compared with coefficient of fat absorption of 81.1% for the lower dose of Zenpep.
The study was done in 76 evaluable patients at 19 sites in the US, Italy and Ukraine. The most common adverse events reported during the trial was gastrointestinal complaints, predominantly flatulence and abdominal pain.

Commenting on the results, Phillip Toskes, Professor of Medicine in the Division of Gastroenterology, Hepatology and Nutrition at the University of Florida College of Medicine said, "The safety and efficacy benefits of Zenpep for chronic pancreatitis patients with EPI are clearly demonstrated in this study. Even the lower dose of Zenpep was found to be beneficial to improve fat and protein absorption and reduce EPI symptoms."

Earlier, Zenpep has received approval for the treatment of exocrine pancreatic insufficiency. The approval was under Risk Evaluation and Mitigation Strategy to ensure that the benefits of the drug outweigh its risks.

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