DigestiveCare has received FDA approval for Pertzye (pancrelipase delayed-release capsules) for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions. This pancreatic enzyme product contains bicarbonate-buffered enteric-coated microspheres which minimize the destruction or inactivation of the enzymes in gastric acid.
Each Pertzye delayed-release capsule strength contains the specified amounts of lipase, protease and amylase as follows:
- 8,000 USP units of lipase; 28,750 USP units of protease; 30,250 USP units of amylase.
- 16,000 USP units of lipase; 57,500 USP units of protease; 60,500 USP units of amylase.
The short-term safety and efficacy of Pertzye were evaluated in a randomized, multicenter, double-blind, placebo-controlled, crossover study conducted in patients ages 8 to 43 years with EPI due to CF. The primary efficacy endpoint was the mean difference in coefficient of fat absorption (CFA) between Pertzye and placebo treatment. Mean CFA was 83% with Pertzye treatment compared to 46% with placebo treatment (p<0.001).
For more information call (877) 882-5950 or visit www.digestivecare.com.