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

MARIETTA, Ga., Oct. 26 /PRNewswire/ -- Solvay Pharmaceuticals, Inc. announced today that new data demonstrate that CREON®( )(pancrelipase) Delayed-Release Capsules significantly improves a key measure of fat absorption in adults with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatic surgery. 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 and, if untreated, can lead to diarrhea, weight loss and ultimately malnutrition.

Findings from this 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, by Dr. David C. Whitcomb, in a poster titled "Efficacy and safety of pancrelipase delayed-release capsules (CREON®) in patients with pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery," poster number P101. 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.

"The maldigestion associated with EPI due to chronic pancreatitis and pancreatic surgeries can result in malnutrition as well as debilitating pain and GI symptoms that negatively impact quality of life for these patients," said David C. Whitcomb, M.D., Ph.D., University of Pittsburgh Medical Center. "These data support the use of PERT to improve the absorption of fat in patients receiving diets of at least 100 g of fat per day, which serves as an important demonstration to clinicians that EPI can be effectively treated without restricting patients' diets to be very low in fat."

According to the study results, adults with CP or who have undergone pancreatic surgery, who took CREON®, had an improved coefficient of fat absorption (
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SOURCE Solvay Pharmaceuticals, Inc.
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