Alcresta Pharmaceuticals has received de novo approval from the US Food and Drug Administration (FDA) to market Relizorb (immobilized lipase).

Relizorb is a first-of-its kind digestive enzyme cartridge designed to mimic the normal pancreatic function by breaking down fats in enteral tube feeding formula.

By breaking down these fats from enteral tube feeding formulas prior to ingestion, Relizorb allows for the delivery of increased absorbable calories from fatty acids and monoglycerides to adults who are partially or completely unable to breakdown and absorb fats.

Fat malabsorption is most common in individuals who cannot produce adequate amounts of digestive enzymes because of compromised pancreatic function.

In certain people, changes in gastric, duodenal, liver and pancreatic physiology can also dramatically impact malabsorption of critical nutrients in particular fat absorption.

In these individuals, incomplete hydrolysis (break down) of fats from enteral tube feeding can lead to decreased caloric intake, reduced digestion of essential fats, in particular long-chain polyunsaturated fatty acids (omega-3), deficiencies of fat-soluble vitamins and increased gastrointestinal symptoms.

These negative outcomes can significantly impact quality of life and nutritional status and can adversely affect a person’s ability to maintain or gain weight and absorb necessary nutrients.

Many patients face the challenge of attaining proper nutrition, which is required as a critical part of maintaining overall health and disease recovery. 

It is estimated that more than 344,000 people of all ages in the US are receiving enteral nutrition at home.

There are an additional 613,000 patients in intensive care units (ICU) that use enteral feeding. 

Based on market survey data, 10-20 percent of people with CF and 20-40 percent of people with pancreatic and stomach cancer use enteral tube feeding on a daily basis.

Source: Alcresta Pharmaceuticals