Results Published In Journal of Cystic Fibrosis Confirm CREON(R) (pancrelipase) Delayed-Release Capsules Improves Fat Absorption in Patients With Cysti... (DA) with an indication to treat EPI due ...)

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Results Published In Journal of Cystic Fibrosis Confirm CREON(R) (pancrelipase) Delayed-Release Capsules Improves Fat Absorption in Patients With Cystic Fibrosis

Date:10/9/2009

DA) with an indication to treat EPI due to CF or other conditions based on the results of this clinical study. As the first FDA-approved PERT, CREON® was also the first product in the class to provide a Medication Guide with important dosing information, including instructions for administration to infants and toddlers, which is consistent with the CF Foundation Consensus Conference Guidelines.

Study Details

The double-blind, randomized, placebo-controlled two-arm, crossover study examined the efficacy and safety of CREON® (Pancrelipase) Delayed-Release 24,000 lipase unit capsules in subjects aged 12 years or older with EPI due to CF. EPI was confirmed in all subjects by a CFA of <70% without pancreatic enzyme supplementation or fecal elastase <50 micrograms/gram stool within 12 months prior to start of study. Upon analysis of the primary efficacy results, the mean CFA was greater during treatment with CREON® (88.6%) compared with placebo (49.6%), and the difference was statistically significant (p < 0.001). Thus, the study met its primary objective and showed superior efficacy of CREON® over placebo based on CFA. Adverse clinical symptoms including stool frequency, abdominal pain, stool consistency and flatulence, occurred less frequently during treatment with CREON®, compared to treatment with placebo. Additionally, abdominal pain and flatulence were less severe and stool consistency was less watery during treatment with CREON®.

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 p
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SOURCE Solvay Pharmaceuticals, Inc.
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Results Published In Journal of Cystic Fibrosis Confirm CREON(R) (pancrelipase) Delayed-Release Capsules Improves Fat Absorption in Patients With Cysti...(DA) with an indication to treat EPI due ...),Health