Cystic fibrosis (CF) is a genetic disorder characterized by an overproduction of thick mucus in various organs throughout the body. The mucus can clog the pancreatic ducts and lead to a loss or reduction of pancreatic enzymes entering the small intestine causing a condition known as exocrine pancreatic insufficiency (EPI). The lack of pancreatic enzymes makes it difficult to break down food and absorb nutrients for those with CF.
Pancreatic enzyme replacement therapy (PERT) replaces these missing enzymes through pancreatic enzyme products (PEPs) taken with snacks and meals to help break down food. All PEPs contain a combination of three digestive enzymes: lipase, to break down fats; amylase, to break down starch; and protease, to break down proteins.
Physicians may also recommend taking acid-reducing medications such as a proton pump inhibitor (PPI) or H2 blocker to help improve enzyme activity. Older PEPs used to contain pancreatin but newer products contain pancrelipase, a more concentrated version of lipase. Both products are extracted from porcine (pig) pancreas.
Due to varying amounts of enzymes in earlier versions of PEPs, the U.S. Food and Drug Administration now requires all products to be approved through a new drug application.
Creon (spelled Kreon in some countries) is a porcine pancrelipase manufactured by Abbvie. The capsules dissolve in the stomach and release many enteric-coated (stomach acid-resisting) microspheres, which later release enzymes into the small intestine and help break down food particles.
Pancreaze is a porcine pancrelipase manufactured by Vivus. It is a delayed-release capsule containing lipases, proteases, and amylases to help break down food in the small intestine.
Pertzye (formerly known as Pancrecarb) is a porcine pancrelipase currently produced by Digestive Care Inc. As with some of the other treatments, the outer capsule dissolves and releases enteric-coated microspheres. In addition to pancrelipase, Pertzye also contains bicarbonate, which helps lower the pH around the food once it enters the small intestine. The lower pH is to help increase enzyme activity without the need for acid suppression therapies. Pertzye is also approved by the FDA for use in gastrostomy tube (G-tube) feeding.
Ultresa was a porcine pancrelipase that was produced by Aptalis Pharma before being acquired by Allergan. Ultresa was discontinued in 2016.
Viokase is a porcine pancrelipase produced by Allergan. Unlike other pancrelipase products, Viokase is not enterically coated and should be taken with a PPI. Viokase helps break down food in the small intestine.
Zenpep is a porcine pancrelipase manufactured by Allergan. Like other pancrelipase products, Zenpep capsules contain a mixture of amylases, lipases, and proteases for breaking down food.
Relizorb is an FDA-approved lipase product manufactured by Alcresta. It contains lipase enzymes bound to small white beads and is sold in a cartridge. Relizorb is designed specifically for use in G-tubes and helps break down fats.
Sollpura (liprotamase) was a non-porcine-derived pancreatic enzyme therapy that was being developed by Anthera. However, development was halted after the results of a Phase 3 clinical trial (NCT03051490) failed to meet the desired level of efficacy compared with a traditional pancrelipase product.
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