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

- Data Support Safe and Effective Use of CREON(R) to Meet Critical Medical Need for CF Patients -


MARIETTA, Ga., Oct. 9  /PRNewswire/ -- Solvay Pharmaceuticals, Inc. announced today that Phase III data published in the Journal of Cystic Fibrosis showed that CREON® (pancrelipase) Delayed-Release Capsules, the most prescribed pancreatic enzyme replacement therapy (PERT) in the United States, significantly improves a key measure of fat absorption in patients with CF who suffer from exocrine pancreatic insufficiency (EPI). 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 poor growth, poor weight gain and failure to thrive in children with CF.

According to the study results, patients with CF and confirmed EPI had an improved coefficient of fat absorption (CFA) during treatment with CREON® compared to treatment with placebo. CFA is calculated based on measures of fat ingestion and fat excretion; assessing the CFA of a patient is a way to measure the absorption of fat as a percentage of fat intake in patients being tested for EPI. The trial reached statistical significance on its primary endpoint, which was CFA.

"These study results demonstrate that CREON® is effective in decreasing the maldigestion and malabsorption associated with pancreatic insufficiency in patients with cystic fibrosis," said Bruce C. Trapnell, MD, Professor of Medicine and Pediatrics at the University of Cincinnati and Cincinnati Children's Hospital Medical Center. "Patients enrolled in this study had poor fat absorption without treatment, which is commonly associated with uncomfortable gastrointestinal symptoms and severe malnutrition.  In addition to the impressive increase in fat absorption demonstrated in these individuals, the secondary outcomes of the study have important implications for those involved in the care of these patients."

CREON® was approved by the Food and Drug Administration (FDA) 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