Solvay Posts New Data For Creon

Solvay Pharmaceuticals has announced that new data demonstrate that Creon (pancrelipase) delayed-release capsules improves a key measure of fat absorption in adults with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatic surgery.

Findings from the phase III study, which have been submitted to the FDA, were presented at the American College of Gastroenterology Annual Scientific Meeting in San Diego, California, on Sunday, October 25th, titled ‘Efficacy and safety of pancrelipase delayed-release capsules (CREON) in patients with pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery’. Among FDA-approved pancreatic enzyme replacement therapies (PERTs), this study provides important new data to evaluate PERT dosing specifically in patients with EPI due to CP or pancreatic surgery.

According to the study results, adults with CP or who have undergone pancreatic surgery, who took Creon, had an improved coefficient of fat absorption (CFA) as compared to the placebo group. CFA is calculated based on measures of fat ingestion and fat excretion; assessing the CFA of a patient is another way to measure the absorption of fat as a percentage of fat intake in patients being tested for EPI. The primary efficacy endpoint was the change in CFA from baseline to the end of the double-blind treatment period. The CFA improved by 32.1% in the Creon group compared to 8.8% in the placebo group, representing a statistically significant difference between Creon and placebo (P<0.0001).

Elizabeth Mutisya, vice president of US Medical Affairs and chief medical officer at Solvay Pharmaceuticals, said: “These data add to the growing body of evidence supporting the efficacy and safety profile of CREON across multiple conditions while also providing clarity around the appropriate dosing of pancreatic enzyme replacement therapy in these patients. These CREON study results are encouraging as dosing of pancreatic enzymes for patients with EPI due to CP or pancreatic surgery has not previously been well defined.”