Pancreatic enzyme-replacement therapy in CF: considerations for the USA

Abstract

Pancreatic enzyme products (PEPs) have been commercially available since before the passage of the Food, Drug and Cosmetic Act in 1938. They are a vital therapy for patients with cystic fibrosis and exocrine pancreatic insufficiency. PEPs help to enhance absorption of nutrients and thereby play an important role in maintaining good nutritional status and preserving lung function. The benefits of these supplements are not limited to cystic fibrosis and also extend to patients with other conditions, such as chronic pancreatitis. Concerns over the safety and consistency of PEPs have led to the requirement that all PEPs be approved by the US FDA. Clinical studies are currently underway to demonstrate the safety and efficacy of different PEPs, including new formulations that meet FDA guidelines for no enzyme overfill. This review highlights currently available PEPs and new formulations that hold promise for patients with exocrine pancreatic insufficiency.

Keywords::

• cystic fibrosis
• malabsorption
• pancreatic enzyme
• pancreatic insufficiency
• pancrelipase

Financial & competing interests disclosure

Consultant and Advisory Board, Eurand, SpA, Procter and Gamble Co. Lecture fees (honoraria) paid by a commercial entity: Asklepion LLC. Industry-sponsored grants (receive or pending) including contracted research: GlaxoSmithKline. Patents received or pending: patent for behenic acid as a facile means to measure fat absorption. Ownership of stocks, bonds or other securities (other than mutual funds): equity interest in Asklepion, LLC. Stock in US Foods and Pharmaceutical (nonpublicly traded company focusing on infant formula and mineral supplements); Stock in First Merchants Corporation, Kroger. In-kind benefits (travel/accommodations): National Institutes of Health. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing assistance was utilized in the production of this manuscript. Drafting of the manuscript was carried out by representatives from Corinth Group Communications, Inc.; the author was responsible for critical revisions of the manuscript for important intellectual content.