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

MARIETTA, Ga., Oct. 15 /PRNewswire/ -- Solvay Pharmaceuticals, Inc. announced today that new data confirm that CREON® (pancrelipase) Delayed-Release Capsules significantly improves a key measure of fat absorption in children aged 7-11 years who have exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). 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. CREON® has already been approved by the U.S. Food and Drug Administration (FDA) for use in newborn children and all ages above.

Findings from this Phase III study, which have been submitted to the FDA, will be presented during the 23rd Annual North American Cystic Fibrosis Conference (NACFC) in Minneapolis, Minnesota during the general poster sessions. The poster presentation, entitled, "Efficacy and safety of a new formulation of pancrelipase delayed-release capsules (CREON®) in children aged 7-11 years with exocrine pancreatic insufficiency due to CF," poster number 532, will be presented by Dr. Gavin Graff, Penn State Milton S. Hershey Medical Center, Hershey, PA.

In this clinical study, children aged 7-11 years with CF had an improved coefficient of fat absorption (CFA) during treatment with CREON® 12,000-lipase unit capsules at a dose of 4,000 lipase units/g of dietary fat intake per day compared to treatment with placebo. 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 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).

"These data support what physicians have witnessed in treating patients with CREON®, that it is effective in treating ex
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SOURCE Solvay Pharmaceuticals, Inc.
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