UPDATE: FDA Approves Expanded Use of Enzyme Device for Children

The U.S. Food and Drug Administration has approved a device, called RELiZORB®, that helps break down beneficial fats in supplemental nutrition provided via G-tubes.

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UPDATE July 24, 2017: The U.S. Food and Drug Administration (FDA) approved the use of the RELiZORB® digestive enzyme cartridge for children ages 5 to 18 who use a feeding tube. The FDA initially approved use of the enzyme cartridge for tube feeding for people ages 18 and over.

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Almost 90 percent of people with cystic fibrosis take pancreatic enzyme supplements to help them absorb essential vitamins and nutrients. People with CF who have difficulty maintaining a healthy weight often rely on supplemental nutrition through a special feeding tube, known as a gastronomy tube (or G-tube), to meet their nutritional needs. 

The U.S. Food and Drug Administration has approved a device that helps break down beneficial fats in supplemental nutrition provided via G-tubes. The device, called RELiZORB®, is a cartridge containing digestive enzymes that is placed in line between the supplemental nutrients and the G-tube and allows for fats in the formula to be predigested.

The active ingredient in RELiZORB® is iLipase®, a combination of the digestive enzyme lipase attached to a polymeric carrier. As the tube feeding formula passes through the cartridge, it makes contact with the iLipase and the fat in the formula is broken down to its absorbable form. The iLipase remains in the cartridge and does not become part of what is ingested. 

This approach simplifies the use of enzyme supplements for people with CF who have multiple needs, including those who require overnight tube feeding or are in intensive care units.

The device improves the absorption of beneficial fatty acids, including omega-3 fatty acids and other critically important “good fats.” Low levels of certain fatty acids contribute to inflammation, and inadequate absorption of fats can negatively affect an individual's ability to maintain or gain weight and absorb the nutrients necessary for overall health.

According to the CF Foundation's 2014 Patient Registry Annual Data Report, more than 11 percent of individuals with CF use supplemental tube feeding to get the nutrition they need. Registry data show that nutrition status and lung function are related, and improvements in body mass index (BMI) are associated with increased pulmonary function.

RELiZORB® was developed by Alcresta Inc., a specialty pharmaceutical company focused on enzyme-based products for gastrointestinal and rare diseases. In 2013, Cystic Fibrosis Foundation Therapeutics, Inc. committed $1.6 million to Alcresta to accelerate the development of the device. CFFT is the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation.

Learn more about cystic fibrosis and nutrition.

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