Creon (pancrelipase, from Solvay Pharmaceuticals) delayed-release capsules, a pancreatic enzyme product (PEP), has received FDA approval for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions under the new guidelines for this class of drugs. This approval was based on results from a randomized, double-blind, placebo-controlled, crossover study in 32 patients with CF. The primary endpoint was the coefficient of fat absorption (CFA). Creon produced significantly greater mean CFA values compared to placebo; the mean CFA during treatment with CREON was 89% versus 49% with placebo. Statistically significant increases in CFA were shown for both adults (>18 years old) and adolescents (12–18 years).
Creon delayed-release capsules are expected to be available in the 3rd quarter of 2009. The currently marketed formulation of Creon will continue to be available until the launch of the new FDA-approved product.
For more information call (800) 354-0026 or visit www.CREON-US.com.