Singapore, Feb 08, 2010: Solvay Pharmaceuticals said that the phase IIIb data published in the journal Clinical Therapeutics confirm that CREON 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.

In this clinical study, children aged 7-11 years with EPI due to CF experienced 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 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 percent) compared to treatment with placebo (47.4 percent), which resulted in a significant difference of 35.4 percent.

Results were similar for a secondary outcome measure of the study, the coefficient of nitrogen absorption (CNA). CNA was used as a measure to evaluate the absorption of proteins. CNA is calculated based on the amount of nitrogen intake and nitrogen excretion. The mean CNA was greater during treatment with CREON (80.3 percent) compared to treatment with placebo (45 percent), which resulted in a significant difference of 35.3 percent.

"If not treated properly, EPI can lead to maldigestion and serious malabsorption of key nutrients, which can be life-shortening. CREON was effective in improving CFA and CNA, which should help maintain adequate nutrition and normal growth in young children with EPI due to CF," said Dr Gavin Graff, Penn State Milton S. Hershey Medical Center, Penn State Medical School.

Findings from this phase IIIb study have been submitted to the FDA. 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 therapy (PERT) for the treatment of children.

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. 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.