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Relizorb, a “first-of-its kind digestive enzyme cartridge designed to mimic the normal pancreatic function,” recently received FDA approval.
Fat malabsorption can be a major problem in people who have compromised pancreatic function and rely on enteral tube feeding, but a new digestive enzyme cartridge is designed to help these individuals break down fats, including long-chain polyunsaturated fatty acids like omega-3s.
Alcresta Pharmaceuticals (Newton, MA) announced last week that Relizorb, its “first-of-its kind digestive enzyme cartridge,” has received de novo approval from FDA. Relizorb is meant to mimic normal pancreatic function by breaking down fats in the formula for enteral tube feeding-which can otherwise be challenging to absorb for many adults suffering from cystic fibrosis, pancreatic cancer, or stomach cancer, says Alcresta.
“The FDA clearance for Relizorb signifies a critical first step forward in our ongoing commitment to developing additional enzyme-based products designed to improve the overall health of people with gastrointestinal and rare diseases, as well as those with specific nutritional needs,” says Robert Gallotto, co-founder and president, Alcresta. “This is the first in a number of enzyme-based products in development to support the management of patients suffering from acute or chronic conditions that impact nutritional needs.”
Long-chain polyunsaturated fatty acids, including omega-3s, can be some of the most difficult essential fats for people with compromised pancreatic function to absorb, according to Alcresta. The Relizorb cartridge seeks to improve absorption of these and other fats through Alcresta’s proprietary enzyme immobilization technology and the active ingredient iLipase, a digestive enzyme lipase attached to polymeric carriers.
“As the enteral tube feeding formula passes through Relizorb, it makes contact with the iLipase and the fat in the formula is broken down to its absorbable form (fatty acids and monoglyceides) prior to ingestion,” says Alcresta. “The iLipase remains in the cartridge and does not become part of what is ingested.”
Relizorb may be able to break down up to 90% of fats in enteral feeding tube formulas, says Alcresta.
“This is an important development for people with cystic fibrosis, especially those who rely on tube feeding as an important source of supplement nutrition,” says Preston Campbell, MD, president and CEO of the Cystic Fibrosis Foundation (Bethesda, MD). “We congratulate Alcresta on the approval of this new treatment approach.”
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