Eurand, a specialty pharmaceutical company, today announced the initiation of the second of two Phase III clinical trials required for registration of its pancreatic enzyme product (PEP), EUR-1008, in patients with exocrine pancreatic insufficiency (EPI). 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. It will involve approximately ten clinical study sites in the U.S. Patient enrollment has commenced and is expected to be complete by end of the third quarter 2006. Results of the study are expected in the fourth quarter of 2006.