Phase III Pediatric Supportive Study Results
This open label study in CF patients under the age of seven involved a seven-day dose stabilization period followed by a seven-day treatment period. The study evaluated the percentage of "responders," or those patients without excess fat in stools and without signs and symptoms of malabsorption after one and two weeks of treatment. Secondary endpoints included weight change, nutritional status, stool frequency and consistency, incidences of bloating, pain and flatulence as well as physician and parent or guardian judgment of clinical symptoms improvement.
In the study, malabsorption symptoms were significantly lower at the end of treatment than at screening, consistent with control of malabsorption symptoms with Zentase in the pivotal phase III trial.
EPI and Cystic Fibrosis
EPI is a deficiency of digestive enzymes normally produced by the pancreas. The deficiency leads to malnutrition, impaired growth in children and shortened life expectancy. EPI is commonly associated with cystic fibrosis and chronic pancreatitis.
Cystic Fibrosis affects about 30,000 individuals in the US and 100,000 worldwide. Approximately 90 percent of these individuals suffer from EPI. Treatment with PEPs helps replace enzymes lost through this disease. Other than enzyme replacement, Eurand is not aware of any other alternative therapy for EPI.
Zentase is a zero-overfill, highly-stable, porcine-derived pancreatic enzyme replacement therapy designed to treat EPI, a deficiency of digestive enzymes normally produced by the pancreas.
Zentase closely mimics the enzyme profile of normal human
pancreatic secretions. Formulated with eight key enzymes and other
co-enzymes and cofactors required for proper digestion, Zentase is
highly stable and requires no product overfill. The product is
being developed in multiple strengths as well as a pediatric