- Supplemental Data Confirm Safe And Effective Use Of Pancreatic Enzyme Replacement Therapy To Meet Medical Need For Pediatric Patients - 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 exocrine pancreatic insufficiency in children with CF to help maintain adequate nutrition and normal growth," said Gavin Graff M.D. While CREON® is already FDA-approved and indicated for the treatment of EPI due to CF and other conditions in patients ages zero and above, Solvay Pharmaceuticals is committed to the continued clinical study and development of CREON® as further confirmation of the safety and efficacy of pancreatic enzyme replacement therapies (PERTs) as described in medical literature and through clinical experience. The safety and efficacy of PERTs with different formulations of pancrelipase consisting of the same active ingredient as CREON® (lipases, proteases, and amylases) for treatment of children with exocrine pancreatic insufficiency due to cystic fibrosis have been described in the medical literature and through clinical experience. There is a history of using different formulations of CREON® to treat pediatric patients with EPI due to CF, which has demonstrated efficacy and safety in those patients through years of clinical experience. In addition to the supplemental CREON® pediatric data, data which supported the recent FDA approval of CREON® are also being presented at NACFC in a poster authored by Dr. Bruce Trapnell, entitled "Pancrelipase delayed-release capsules (CREON®) in patients with pancreatic insufficiency due to cystic fibrosis: Age and severity analyses," during the general poster sessions. Pediatric Study Details The double-blind, randomized, multi-center, placebo-controlled, cross-over study examined the efficacy and safety of CREON® (pancrelipase) Delayed-Release 12,000 lipase unit capsules in 16 subjects ages 7-11 years with EPI due to CF. EPI was confirmed in all subjects by a CFA of