Efficacy of a Novel Pancreatic Enzyme Product, EUR-1008 (Zenpep), in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis

Objectives: EUR-1008 (ZENPEP (R) [pancrelipase] Delayed-Release Capsules)(a) delayed-release capsules is a novel, enteric-coated, porcine-derived pancreatic enzyme product. This study evaluated the efficacy and safety of 2 doses of ZENPEP in patients with chronic pancreatitis (CP) and exocrine pancreatic insufficiency (EPI). Methods: The effect of ZENPEP on the coefficient of fat absorption (CFA) was investigated in a randomized, double-blind, dose-response, crossover study with placebo run-in (7-9 days) and 2 treatment periods (9-11 days) composed of a high dose (7 x 20,000 lipase units per day) and a low dose (7 x 5000 lipase units per day). Results: Mean CFA was significantly higher with low- (88.9%) and high-dose (89.9%) ZENPEP versus placebo run-in (82%; P < 0.001; n = 72) with no difference between doses (P = 0.228, primary end point). In patients with baseline CFA less than 90% (n - 33), the high dose was significantly more effective (CFA: 84.1%) than the low dose (CFA: 81.1%; P < 0.001). Post hoc analysis revealed an increase in treatment effect with more severe EPI. Coefficient of nitrogen absorption (P < 0.001), body weight (P <= 0.021), and body mass index (P <= 0.020) also increased significantly with both doses compared with baseline. Percentage of days with EPI symptoms decreased with both doses. Conclusions: Our findings suggest that CP patients with EPI benefit from a low dose of ZENPEP, whereas the high dose might be needed for patients with more severe EPI.