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Eurand Pancreas Drug Enters Second Late-Stage Trial

Posted on: Thursday, 11 May 2006, 21:04 CDT

Eurand has initiated the second of two phase III clinical trials required for registration of its pancreatic enzyme product, EUR-1008, in patients with exocrine pancreatic insufficiency.

Exocrine pancreatic insufficiency (EPI) is a deficiency of digestive enzymes normally produced by the pancreas which leads to malnutrition, impaired growth and shortened life expectancy. EPI can result from a number of diseases and conditions, including cystic fibrosis (CF), chronic pancreatitis and pancreatic cancer.

The trial is designed to determine the safety and tolerability of EUR-1008 in children under the age of seven. The trial will involve approximately ten clinical study sites in the US.

Results of the study are expected in the fourth quarter of 2006. The protocol for the trial has been prepared in collaboration with the Cystic Fibrosis Foundation.

EUR-1008 has been developed as a delayed-release capsule intended to provide consistent product dosing over time. A low dose, micro-tablet formulation has been specifically developed for young children.

"The correct treatment of pancreatic insufficiency is fundamental to the management of cystic fibrosis in young children, this pediatric trial will further evolve our understanding of the disease and how best to treat our patients," said Dr Jamie Wooldridge, assistant professor of pulmonary medicine at Children's Hospital Medical Center, Cincinnati, and the lead investigator for the trial.

Source: Datamonitor

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