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CREON(R) (pancrelipase) Delayed-Release Capsules Improves Digestive Outcomes In Adults With Chronic Pancreatitis
Date:10/26/2009

he CREON® group and 8.8% in the placebo group, with a statistically significant difference between CREON® and placebo (p < 0.0001). Thus, the study met its primary objective, showing a superior efficacy of CREON® over placebo on the key measure of CFA. Overall symptoms of maldigestion improved from baseline to a greater extent in CREON®-treated patients compared with placebo, with significantly greater improvements in stool characteristics, flatulence, and stool consistency. CREON® was well-tolerated and had a similar adverse event profile to that of placebo. A low number of treatment-emergent adverse events were reported; primarily gastrointestinal events and metabolic/nutritional disorders.

About Exocrine Pancreatic Insufficiency and Pancreatic Enzyme Replacement Therapy

Exocrine pancreatic insufficiency (EPI) is a condition resulting from a deficiency in the production and/or secretion of pancreatic enzymes that are necessary to digest nutrients in food. The safety and efficacy of prior formulations of pancrelipase in pediatric patients with EPI due to CF have been described in the medical literature. Prior formulations of pancrelipase have also demonstrated clinical efficacy in those patients through years of clinical experience. PERTs work in patients with EPI by delivering pancreatic enzymes to the small intestine to help break down fats, proteins and carbohydrates in food, thereby acting as a replacement for digestive enzymes physiologically secreted by the pancreas. EPI can occur as a complication of a variety of diseases or conditions, including CF, pancreatic cancer, gastrointestinal surgery and chronic pancreatitis. Statistics show that more than 80% of CF patients have EPI, which usually develops during the first year of life.

The original products in the pancreatic enzyme drug class pre-date modern FDA regulatory requirements. Over the past two decades, products in this class
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SOURCE Solvay Pharmaceuticals, Inc.
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