Healthy Living

Cystic Fibrosis: FDA Extends Use of Relizorb to Children

Cystic Fibrosis: FDA Extends Use of Relizorb to Children

The ability to gain and maintain a healthy weight for patients who suffer from cystic fibrosis can be a challenge. Many children with the condition suffer from failure to thrive. The disorder has the tendency to cause a blockage in digestion that prevents necessary fats from being absorbed. Proper nutrition plays a vital role in anyone being healthy, but it is essential for cystic fibrosis patients. The healthier the patient is from a nutrition standpoint, the less chance of other complications from the disease. Many patients end up needing a feeding tube so they can bulk up on calorie intake. The fat content in the feeding tube formula still needs assistance being absorbed into the patient's body. Enzyme replacement therapy can be a huge part of success in these patients. The FDA has just announced that it has approved the use of a successful enzyme cartridge for use in children.

What is Relizorb?

The medication is called Relizorb. It was first approved by the FDA in 2015 as the first digestive enzyme cartridge of its kind. It was developed to help aid in the digestion of adults that require tube feeding as part of a healthy intake. These patients are often suffering from a disease or disorder like cystic fibrosis. The company responsible for the development of the medication is Alcresta. In 2013, they received an award from a branch of the Cystic Fibrosis Foundation called Cystic Fibrosis Foundation Therapeutics. They are a nonprofit division of the Cystic Fibrosis Foundation that is responsible for the discovery and development of new medications. The approval of this medication was a major step in the management of nutrition in adult patients requiring feeding and a detrimental step for cystic fibrosis patients. The drug, however, was not initially approved for use in children. Continuous studies by the pharmaceutical company have now led to the approval for use in children from ages 5 and up.

Fat is important for CF

Most Americans are under the impression that fat is a bad thing and in some instances, it is. The right fat, however, is a necessary part of a healthy diet. Everyone has heard of the importance of omega-3 fatty acids. Often found in fish and nuts, these fats are the ones we don’t want to cut out of our diet. These fats are essential for the body to function properly and they have some pretty significant health benefits. These fats are not able to be made by the body, so the consumption of them has to come from food. DHA and EPA are a couple of these fats and have been linked to lowering blood sugar, reducing memory loss, and improving overall cardiac health. Anyone who has ever been pregnant has heard of DHA. It is a very important fatty acid that plays a key role in newborn brain development. Many of the pre-natal vitamins on the market contain a high amount of DHA. These are the types of fats that patients with cystic fibrosis are usually unable to absorb on their own and therefore end up with issues like weight loss or inability to gain weight.

What is Pancreatic Enzyme Therapy?

The pancreas is an organ that must be fully functioning in order to achieve proper digestion of the food that enters into the body. It is responsible for releasing enzymes that aid in the proper digestion of fats, proteins, and carbohydrates. When a condition like cystic fibrosis causes a blockage of the pancreas, it leads to these enzymes being unable to be released. This is referred to as pancreatic insufficiency. There are oral forms of enzyme supplements that replace the missing natural enzymes and help patients digest food and also reduce fatty stools. These medications must be dosed properly in order to work or they can have serious side effects.

Relizorb works the same way, only it is specifically designed for use in feeding tubes. There are three enzymes naturally produced in the body that aid in food digestion: Protease, Amylase, and Lipase. Protease breaks down the proteins and Amylase breaks down the carbs. Lipase is the enzyme that is responsible for breaking down fat. Relizorb is a lipase supplement that replaces the missing enzyme when fed through a tube.

Why the need?

Many families involved in the care of someone living with cystic fibrosis already have the answers to the question why there is a need for therapies such as Relizorb. In a healthy body, the pancreas releases enzymes that are necessary to help the intestines properly digest food and properly absorb the vital nutrients of this food. A large percentage of patients with cystic fibrosis have pancreatic insufficiency. This is also the reason many patients have fatty stools. Without the ability to absorb food properly, patients end up underweight and unhealthy due to poor nutrition. Children with cystic fibrosis usually require a higher number of calories than healthy children of the same age. It becomes even more important to raise the calorie intake of a cystic fibrosis patient when they are fighting an illness. Children have a naturally high amount of energy most of the time. If they are burning a lot of calories trying to be a kid, yet not taking in a sufficient number of calories, it leads to problems. Any human needs calories to function properly; it is fuel. This concept isn’t that straightforward for a cystic fibrosis patient. They become more vulnerable to illness, exhaustion, and in severe cases even die of starvation. Maintaining a higher body weight often means better lung function in cystic fibrosis cases.

How does it work?

Relizorb is an innovative little device. It easily hooks onto the line of existing feeding tubes and connects with most systems. The cartridge is filled with the substance that mimics the missing lipase attached to tiny white beads. Relizorb trademarked this unique lipase supplement and bead combination. They call it iLipase. Feeding formula passes through the tube as normal. When the formula makes contact with the Relizorb cartridge, the fat in the formula is broken down. The formula is then able to enter the body already in absorbable form.

A nod to the scientists

This medication is possible thanks to the ongoing research of Alcresta Therapeutics, a company dedicated to products that help patients living with gastrointestinal disorders and rare disease. The company started in 2011 and has grown leaps and bounds since then. It is a highly skilled group that has undeniable experience in nutritional product development. These scientists focus on innovative pharmaceuticals and devices that maximize the nutritional intake of patients and they play a huge role in aiding patients with cystic fibrosis.

What this means for children

The approval of this drug for use in pediatric patients is a game changer. This means more children that require caloric increase through a feeding tube will have a better success at absorbing the necessary fats from the formula. Devices like Relizorb give these patients a better chance at success when it comes to proper intake of fats. It not only allows the probability of weight gain, but it also decreases other symptoms such as high fat content in stools and stomach pains. This means a healthier patient in the end. The effects of malnutrition on the body are undeniable. If these otherwise failing to thrive patients are able to start gaining weight, it means improved overall function. It means less exacerbation of symptoms because the body has the fuel it needs.