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CREON(R) (pancrelipase) Delayed-Release Capsules Improves Absorption of Fat in Young Children With Cystic Fibrosis
Date:10/15/2009

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Upon analysis of the primary efficacy results, the mean CFA was greater during treatment with CREON® (82.8%) compared to treatment with placebo (47.4%), which resulted in a significant difference of 35.4% (p < 0.001). Thus, the study met its primary objective and showed a superior efficacy of CREON® over placebo based on the CFA. Treatment-emergent adverse events, which were predominantly gastrointestinal events, were reported in five patients during treatment with CREON® and nine patients during treatment with placebo.

About Exocrine Pancreatic Insufficiency and Pancreatic Enzyme Replacement Therapies

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 have been allowed to be marketed as prescription drugs without formal NDA approval. In 2004, the FDA required manufacturers to submit New Drug Applications (NDAs) for all panc
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SOURCE Solvay Pharmaceuticals, Inc.
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