Eurand N.V. (EURX) announced data from a Phase II/III clinical study demonstrating that ZENPEP Delayed-Release Capsules significantly improves fat absorption in patients with exocrine pancreatic insufficiency, or EPI, due to chronic pancreatitis.
In a double-blind, randomized, dose-response control, crossover study conducted in 19 sites in the United States, Italy and Ukraine in 76 evaluable patients, two dosage regimens of ZENPEP were evaluated. Patients with overall mild-to-moderate EPI associated with chronic pancreatitis experienced significant improvement in fat and protein absorption and body weight with ZENPEP at both a lower dose of 35,000 lipase units/day and higher dose taken with meals.
The mean CFA was 88.9% and 89.9% with the ZENPEP lower and higher dose, respectively. In a subgroup of patients with more severe EPI, the higher dose of 140,000 lipase units/day was more effective than the lower dose. Both ZENPEP daily doses were safe and well tolerated.
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