Such drugs only came under FDA regulatory guidance in 2004.

FDA has approved Eurand’s Zenpep delayed-release capsules as a treatment for exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions. The drug will be available during the fourth quarter in four dosage strengths to meet the needs of infants, toddlers, adolescents, and adults.

EPI is the inability to properly digest food due to a lack of digestive enzymes made by the pancreas. Historically, pancreatic enzyme products (PEPs) have not been regulated by the FDA. In 2004 due to inconsistent quality that affected the safety and efficacy of PEPs, the agency determined it was necessary to better control these products.

FDA’s guidance on PEPs outlined the need to reduce the variability in enzyme levels, address stability issues associated with unapproved enzyme therapies, and regulate them under NDAs. All manufacturers of EPI drug products were required to file NDAs and receive marketing approvals by April 2010.

Zenpep is a highly stable formulation of a porcine pancreatic extract that is biologically similar to the endogenous human pancreatic secretions necessary for proper human digestion, Eurand notes. It works to replace the missing digestive enzymes to improve digestion and absorption.

“For years, patients with EPI taking unapproved PEPs have lived with far too much variability in the control of their gastrointestinal symptoms as a result of product instability and dosing inconsistency,” points out Gearoid Faherty, chairman and CEO.

 “The availability of clinical evidence in a pediatric population is particularly important for EPI patients with CF and their caregivers, as early improvements in BMI significantly affect long-term survivability,” comments Jamie Wooldridge, M.D., principal investigator in the Zenpep pediatric trial. Zenpep capsules are formulated to allow the contents to be sprinkled on food when necessary.

“In preparation for our U.S. launch we have built and continue to expand a first-rate commercial organization to help Zenpep reach its full market potential,” Faherty says. The company will market the drug through its own sales force to the different physicians that treat EPI within each of the target CF and non-CF patient populations.

“Eurand intends to deploy a sales force of sufficient size and scope to address these distinct market segments,” Faherty states. “To accelerate adoption, we will also have an extensive sampling and patient support program for a period of time following the launch.”

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