Solvay Pharmaceuticals has reported that the FDA approved Creon delayed-release capsules for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
Creon is reported to be the first and only pancreatic enzyme product to receive FDA approval under new guidelines for the class.
According to Solvay, the efficacy of FDA-approved Creon was demonstrated in a randomized, double-blind, placebo-controlled crossover study which enrolled 32 patients with cystic fibrosis. The primary efficacy endpoint was the coefficient of fat absorption (CFA), which measures the percentage of fat absorption relative to dietary fat intake.
Creon produced significantly greater mean CFA values compared to placebo in this study. The mean CFA during treatment with Creon was 89% versus 49% during treatment with placebo, representing a mean difference in CFA of 41%. Creon showed statistically significant increases in CFA for both adults (age >18 years) and adolescents (age 12-18 years), the company said.
The FDA-approved formulation of Creon is targeted to become commercially available in the third quarter of 2009. The currently marketed formulation of Creon will continue to be commercially available until the launch of the FDA-approved product.
Stephen Hill, president of Solvay Pharmaceuticals, said: As the first and only product in the pancreatic enzyme class to be FDA-approved under the new guidelines, Creon helps meet a critical need for thousands of patients with exocrine pancreatic insufficiency.