FDA approves digestive enzyme cartridge for enteral tube feeding

Issue: February 10, 2016

Alcresta Pharmaceuticals announced FDA “de novo” approval of Relizorb, the first digestive enzyme cartridge manufactured for patients receiving enteral tube feeding.

In the release, the manufacturer describes Relizorb as a “first-of-its-kind” enzyme cartridge, from which patients can obtain a reflection of normal pancreatic function. The cartridge is designed to break down fats in enteral tube formula prior to patient ingestion, allowing them to absorb more calories despite their own inability to break down and absorb fats. This malabsorption is common in those with impaired pancreatic function, but also seen in those with impaired gastric, duodenal and liver physiology.

Particularly, patients with cystic fibrosis (CF) utilize enteral tube feeding and studies have shown better nutrition and weight gain in CF correlate with better outcomes.

“This is an important development for people with cystic fibrosis, especially those who rely on tube feeding as an important source of supplemental nutrition,” Preston Campbell, MD, president and CEO of the Cystic Fibrosis Foundation, said in the release. “We congratulate Alcresta on the approval of this new treatment approach.”

More than 344,000 people receive home-based enteral nutrition and intensive care units account for 613,000 more, according to the release. Of patients with CF, 10% to 20% utilize enteral feeding while 20% to 40% of those with pancreatic or stomach cancer utilize it daily.

“The approval of our flagship enzyme-based product Relizorb marks an important and hopeful day for the thousands of people who rely on daily enteral feeding to support their medical and nutritional needs,” John Tucker, CEO of Alcresta, said in the release. – by Katrina Altersitz

Disclosures: Healio Gastroenterology was unable to confirm relevant financial disclosures of Campbell at the time of publication. Tucker reports he is an employee of Alcresta.