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

ocrine 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 <70% without pancreatic enzyme supplementation or pancreatic elastase <50 micrograms/gram stool within 12 months prior to start of stud
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SOURCE Solvay Pharmaceuticals, Inc.
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