ABBOTT PARK, Ill.., May 3 Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for CREONŽ (pancrelipase) Delayed-Release Capsules that now includes dosing guidance in the prescribing information specific to patients with limited production of enzymes in the pancreas (exocrine pancreatic insufficiency) due to chronic pancreatitis (CP) or removal of the pancreas (pancreatectomy). Prior to this FDA approval, dosing guidance for medications such as CREON was based on patients with cystic fibrosis.
Exocrine pancreatic insufficiency (EPI) is the inability to properly digest food due to a lack of digestive enzymes made by the pancreas. Patients with chronic pancreatitis or those who have had their pancreas removed (to manage conditions of the pancreas such as CP, pancreatic cancer or pancreatic tumors) often develop EPI. This insufficiency reduces the production or secretion of enzymes that are necessary to digest nutrients in food and can result in a type of oily diarrhea known as steatorrhea, malabsorption of nutrients, weight loss and even chronic malnutrition if left untreated.
With this FDA approval, CREON is the first medication in its class to have this guidance and information in its prescribing information for use in treating EPI due to CP and pancreatectomy.
"Without proper dosing guidance, some patients have previously attempted to control EPI symptoms by modifying their diets and limiting fat intake," said Orelle Jackson, executive director of the National Pancreas Foundation. "However, this approach has yielded limited treatment success."
The sNDA approval was based on results of a double-blind, randomized, placebo-controlled, two-arm, parallel-group study which enrolled 54 adults with EPI due to CP or pancreatectomy. The primary efficacy endpoint was a clinical measurement of how much fat consumed by a patient is absorbed by the body rather than excreted.
"Until now, patients who have had their pancreas removed or those with chronic pancreatitis have too often received inadequate doses of pancreatic enzymes to address their symptoms," said David C. Whitcomb, M.D., Ph.D., University of Pittsburgh Medical Center. "The availability of new data for CREON is a benefit to prescribers by providing appropriate dosing information that can impact the treatment of these patients."
About Pancreatic Enzyme Replacement Therapy
In April 2009, CREON became the first Pancreatic Enzyme Replacement Therapy (PERT) to receive approval under the FDA's new guidelines for the class for the treatment of EPI due to cystic fibrosis or other conditions and has been available to patients in its FDA-approved formulation since July 2009. PERTs work in patients with EPI by delivering pancreatic enzymes to the small intestine to help break down fats, proteins and carbohydrates in food, thereby acting as a replacement for digestive enzymes physiologically secreted by the pancreas. EPI can occur as a complication of a variety of diseases or conditions, such as cystic fibrosis, chronic pancreatitis, pancreatic cancer and gastrointestinal surgery.
The original products in the PERT class pre-date the modern FDA regulatory requirements. Over the past two decades, products in this class have been allowed to be marketed as prescription drugs without formal New Drug Application (NDA) approval. In 2004, the FDA required manufacturers to submit NDAs for all PERTs in order to remain on the market. By the end of April 2010, all PERTs were required to have approved NDAs and be manufactured under the new guidelines.
CREON (pancrelipase) Delayed-Release Capsules is a prescription pancreatic enzyme medicine used to improve food digestion in people who cannot digest food properly because they have exocrine pancreatic insufficiency.
Important Safety Information
CREON may increase the chance of having a serious bowel disorder called fibrosing colonopathy. The risk of having this condition may be reduced by following the dosing instructions.
CREON capsules or the contents of the capsules should not be crushed or chewed because this may cause mouth irritation. CREON should be taken during a meal or a snack and followed with sufficient fluid. CREON can cause allergic reactions such as unusual or severe stomach pain, worsening of gout, or painful, swollen joints, trouble with breathing, skin rashes or swollen lips. The most common side effects include: gassiness (flatulence), headaches, stomach area (abdominal) pain and dizziness.
Full Prescribing Information, including the Medication Guide, is available at www.CREON.com.
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