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news.A phase IIIb data published in the journal, Clinical Therapeutics, confirm that Solvay Pharmaceuticals' Creon (pancrelipase) delayed-release capsules has shown to improve a key measure of fat absorption in children aged 7-11 years, who have exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
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In the clinical study, children aged 7-11 years with EPI due to CF experienced an improved coefficient of fat absorption (CFA) during treatment with Creon, as compared to treatment with placebo.
The study is a short-term, double-blind, randomised, multicenter, placebo-controlled, cross-over study. It examined the efficacy and safety of Creon (pancrelipase) delayed-release 12,000 lipase unit capsules at a dose of 4,000 lipase units/g of dietary fat intake per day for five days, in 16 patients aged 7-11 years with EPI due to CF.
EPI was confirmed in all subjects by a CFA of < 70% without pancreatic enzyme supplementation or human fecal elastase < 50micrograms/gram stool within 12 months prior to start of study.
In the study, 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 difference of 35.4%.
Reportedly, the 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%) compared to treatment with placebo (45.0%), which resulted in a significant difference of 35.3%.
The company said that the findings from the 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.