The trial is designed to determine the safety and tolerability of EUR-1008M and will compare the active drug to placebo in improving absorption of fat and other nutrients. It will involve approximately 20 clinical study sites in the US. Patient enrollment has already begun and is expected to be complete by end of June 2006. Results of the study are expected in the fourth quarter of 2006.
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, chronic pancreatitis and pancreatic cancer.
EUR-1008M is a new pancreatic enzyme product developed by Eurand. It has been developed as a delayed-release capsule intended to provide consistent product dosing over time, and EUR-1008M will be available in multiple dosage strengths to provide flexibility and convenience in dosing.
Gearoid Faherty, CEO of Eurand said: “This new product builds on our 15 years of experience in developing and manufacturing pancreatic enzyme products and we believe that if these phase III trials are successful, EUR-1008M could represent a significant advance in the treatment of pancreatic insufficiency.”
An additional trial of EUR-1008M in a pediatric population is expected to commence in the second quarter of 2006.