The FDA has approved Zenpep (pancrelipase delayed-release capsules, from Eurand N.V.), a pancreatic enzyme product (PEP) for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions. This approval was based on data from two Phase 3 multicenter clinical trials in children and adults with CF and EPI. In the placebo-controlled, randomized, double-blind pivotal study in older children and adults (7–23 years of age), the primary efficacy endpoint, the mean Coefficient of Fat Absorption (CFA), was statistically higher in patients treated with Zenpep than placebo (88.3% versus 62.8%, respectively; p<0.001). In the open-label, single-arm study in young patients (1–6 years of age), patients maintained symptom control when switched from their usual PEP regimen to Zenpep at similar doses.
Zenpep is approved for use in infants, children, and adults. The capsule may be opened and its contents sprinkled on food for administration to infants, very young children, and older adults. Zenpep is expected to be available in the fourth quarter of 2009 in 4 fixed dose capsules containing lipase, protease, and amylase: 5,000USP/17,000USP/27,000USP, 10,000USP/34,000USP/55,000USP, 15,000USP/51,000USP/82,000USP, and 20,000USP/68,000USP/109,000USP.
For more information call (267) 759-9400 or visit www.eurand.com.