MARIETTA, Ga., Oct. 26 Solvay Pharmaceuticals, Inc. announced today that new data demonstrate that CREONŽ( )(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 (CREONŽ) 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 CREONŽ, 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 CREONŽ group compared to 8.8% in the placebo group, representing a statistically significant difference between CREONŽ and placebo (P<0.0001).
"These data add to the growing body of evidence supporting the efficacy and safety profile of CREONŽ 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 CREONŽ 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."
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 CREONŽ 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 CREONŽ 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 CREONŽ group and 8.8% in the placebo group, with a statistically significant difference between CREONŽ and placebo (p < 0.0001). Thus, the study met its primary objective, showing a superior efficacy of CREONŽ over placebo on the key measure of CFA. Overall symptoms of maldigestion improved from baseline to a greater extent in CREONŽ-treated patients compared with placebo, with significantly greater improvements in stool characteristics, flatulence, and stool consistency. CREONŽ 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.
About Exocrine Pancreatic Insufficiency and Pancreatic Enzyme Replacement Therapy
Exocrine pancreatic insufficiency (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. The safety and efficacy of prior formulations of pancrelipase in pediatric patients with EPI due to CF have been described in the medical literature. Prior formulations of pancrelipase have also demonstrated clinical efficacy in those patients through years of clinical experience. 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, including CF, pancreatic cancer, gastrointestinal surgery and chronic pancreatitis. Statistics show that more than 80% of CF patients have EPI, which usually develops during the first year of life.
The original products in the pancreatic enzyme drug class pre-date modern FDA regulatory requirements. Over the past two decades, products in this class have been allowed to be marketed as prescription drugs without formal NDA approval. In 2004, the FDA required manufacturers to submit New Drug Applications (NDAs) for all pancreatic enzyme replacement therapies in order to remain on the market. By April 2010, all pancreatic enzyme replacement therapies are required to have approved NDAs and must be manufactured under the new guidelines.
Important Safety Information
Warnings and precautions include fibrosing colonopathy, a rare, serious adverse reaction that has been described in association with high-dose use of pancreatic enzyme replacement therapy in the treatment of cystic fibrosis patients. Caution should be exercised when doses of CREONŽ( )exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day). Care should be taken to ensure that CREONŽ( )is not chewed or retained in the mouth to avoid irritation of oral mucosa. Caution should be exercised when prescribing CREONŽ( )to patients with gout, renal impairment, or hyperuricemia. There is theoretical risk of viral transmission with all pancreatic enzyme products, including CREONŽ. Caution should be exercised when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.
In the clinical study used to demonstrate the efficacy and safety of FDA-approved CREONŽ, the incidence of adverse events (regardless of causality) was higher during placebo treatment (71%) than during CREONŽ( )treatment (50%). Treatment-emergent adverse events occurring in at least two patients (greater than or equal to 6%) receiving CREONŽ( )or placebo were abdominal pain, abdominal pain upper, abnormal feces, cough, dizziness, flatulence, headache, and weight decreased.
CREONŽ( )has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh its risks. As part of the REMS, a Medication Guide with important dosing and safety information applicable to this class of products, including CREONŽ, is provided for patients and caregivers, with an emphasis on understanding the risk of fibrosing colonopathy as well as the importance of not over- or under-dosing. The FDA requires that the Medication Guide be handed out with every prescription for the drug dispensed.
For full safety and Prescribing Information about the FDA-approved formulation of CREONŽ, visit www.CREON.com.
Solvay Pharmaceuticals, Inc., of Marietta, Georgia, is the U.S. subsidiary of Solvay Pharmaceuticals. For more information, visit www.solvaypharmaceuticals-us.com.
Solvay Pharmaceuticals is a research driven group of companies that constitutes the global pharmaceutical business of the Solvay Group. These companies seek to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardiometabolic, influenza vaccines, gastroenterology and men's and women's health. Its 2008 sales were EUR 2.7 billion and it employs more than 9,000 people worldwide. For more information, visit www.solvaypharmaceuticals.com.
Solvay is an international Chemicals and Pharmaceuticals Group with headquarters in Brussels. It employs some 28,300 people in 50 countries. In 2008, its sales amounted to EUR 9.5 billion generated by its three activity sectors: Chemicals, Plastics and Pharmaceuticals. Solvay (NYSE-Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR) is listed on NYSE-Euronext at Brussels. Details are available at www.solvay.com.
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