New data demonstrates CREON Delayed-Release Capsules improve fat absorption in adults with EPI

Oct 27 2009

Solvay Pharmaceuticals, Inc. announced that new data demonstrate that CREON®( )(pancrelipase) Delayed-Release Capsules significantly improves a key measure of fat absorption in adults with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatic surgery. EPI is a condition resulting from a deficiency in the production and/or secretion of pancreatic enzymes that are necessary to digest nutrients in food and, if untreated, can lead to diarrhea, weight loss and ultimately malnutrition.

Findings from this Phase III study, which have been submitted to the FDA, were presented at the American College of Gastroenterology Annual Scientific Meeting in San Diego, California, on Sunday, October 25th, by Dr. David C. Whitcomb, in a poster titled "Efficacy and safety of pancrelipase delayed-release capsules (CREON®) in patients with pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery," poster number P101. Among FDA-approved pancreatic enzyme replacement therapies (PERTs), this study provides important new data to evaluate PERT dosing specifically in patients with EPI due to CP or pancreatic surgery.

"The maldigestion associated with EPI due to chronic pancreatitis and pancreatic surgeries can result in malnutrition as well as debilitating pain and GI symptoms that negatively impact quality of life for these patients," said David C. Whitcomb, M.D., Ph.D., University of Pittsburgh Medical Center. "These data support the use of PERT to improve the absorption of fat in patients receiving diets of at least 100 g of fat per day, which serves as an important demonstration to clinicians that EPI can be effectively treated without restricting patients' diets to be very low in fat."

According to the study results, adults with CP or who have undergone pancreatic surgery, who took CREON®, had an improved coefficient of fat absorption (CFA) as compared to the placebo group. CFA is calculated based on measures of fat ingestion and fat excretion; assessing the CFA of a patient is another way to measure the absorption of fat as a percentage of fat intake in patients being tested for EPI. The primary efficacy endpoint was the change in CFA from baseline to the end of the double-blind treatment period. The CFA improved by 32.1% in the CREON® group compared to 8.8% in the placebo group, representing a statistically significant difference between CREON® and placebo (P<0.0001).

"These data add to the growing body of evidence supporting the efficacy and safety profile of CREON® across multiple conditions while also providing clarity around the appropriate dosing of pancreatic enzyme replacement therapy in these patients," said Elizabeth M. Mutisya, M.D., Vice President of U.S. Medical Affairs and Chief Medical Officer at Solvay Pharmaceuticals, Inc. "These CREON® study results are encouraging as dosing of pancreatic enzymes for patients with EPI due to CP or pancreatic surgery has not previously been well defined."

Study Details

The double-blind, randomized, placebo-controlled, two-arm, parallel-group study conducted in the United States, Eastern and Central Europe, examined the efficacy and safety of CREON® 12,000-lipase unit capsules in 52 adults aged 18 years or older with EPI due to CP or pancreatic surgery. Patients were randomized to receive CREON® 12,000-lipase unit capsules at a dose of 72,000 lipase units per main meal and 36,000 lipase units per snack or matching placebo. EPI was confirmed in all subjects through direct pancreatic function testing such as, secretin tests or fecal elastase (< 100 micrograms/g), 72-hour fecal fat determination (> 15 g/day) or pancreatectomy more than 180 days prior to study enrollment.

Upon analysis of the primary efficacy results, the mean CFA increased by 32.1% in the CREON® group and 8.8% in the placebo group, with a statistically significant difference between CREON® and placebo (p < 0.0001). Thus, the study met its primary objective, showing a superior efficacy of CREON® over placebo on the key measure of CFA. Overall symptoms of maldigestion improved from baseline to a greater extent in CREON®-treated patients compared with placebo, with significantly greater improvements in stool characteristics, flatulence, and stool consistency. CREON® was well-tolerated and had a similar adverse event profile to that of placebo. A low number of treatment-emergent adverse events were reported; primarily gastrointestinal events and metabolic/nutritional disorders.