FDA Approves Pancrelipase Dosing Guidelines for Chronic Pancreatitis and Pancreatectomy

Yael Waknine

May 04, 2010

May 4, 2010 ( UPDATED May 5, 2010 ) — The US Food and Drug Administration (FDA) has granted specific approval of pancrelipase delayed-release capsules (Creon; Abbott Labs) for the treatment of exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis (CP) and pancreatectomy.

The product is the first pancreatic enzyme replacement therapy to have specific dosing recommendations for CP and pancreatectomy that are not derived from studies of patients with cystic fibrosis.

"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, in a company news release. "However, this approach has yielded limited treatment success."

Uncontrolled EPI can have serious ramifications, resulting in steatorrhea, nutrient malabsorption, weight loss, bloating, abdominal pain, and even chronic malnutrition, if left untreated.

Approval of the new dosing recommendations was based on fat-absorption data from a double-blind, randomized, placebo-controlled, 2-arm parallel-group study of 54 patients with EPI resulting from CP or pancreatectomy.

In the study, patients received delayed-release pancrelipase at a dose of 72,000 lipase units at each of 3 main meals and 36,000 lipase units at each of 2 snack times while consuming at least 100 g fat per day. These reduced starting doses are consistent with the 500 lipase units/kg of body weight per meal lowest starting dose recommended for adults in the Cystic Fibrosis Foundation Consensus Conferences Guidelines.

The FDA notes that dosage should be individualized based on clinical symptoms, the degree of steatorrhea, and dietary fat content. Usually, half of the prescribed meal dose should be given with each snack.

"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, MD, PhD, from the University of Pittsburgh Medical Center, Pennsylvania. "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."

Pancrelipase delayed-release capsules previously were approved for the treatment of EPI caused by cystic fibrosis or other (unspecified) conditions.

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