MARIETTA, Ga., Oct. 15 -- Solvay Pharmaceuticals, Inc. announced today that new data confirm
Findings from this Phase III study, which have been submitted to the FDA, will be presented during the 23rd Annual North American Cystic Fibrosis Conference (NACFC) in Minneapolis, Minnesota during the general poster sessions. The poster presentation, entitled, Efficacy and safety of a new formulation of pancrelipase delayed-release capsules (CREONŽ) in children aged 711 years with exocrine pancreatic insufficiency due to CF, poster number 532, will be presented by Dr. Gavin Graff, Penn State Milton S. Hershey Medical Center, Hershey, PA.
In this clinical study, children aged 7-11 years with CF had an improved coefficient of fat absorption (CFA) during treatment with CREONŽ 12,000-lipase unit capsules at a dose of 4,000 lipase units/g of dietary fat intake per day compared to treatment with placebo. 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 mean CFA was greater during treatment with CREONŽ (82.8%) compared to treatment with placebo (47.4%), which resulted in a significant difference of 35.4% (p < 0.001).
"These data support what physicians have witnessed in treating patients with CREONŽ, that it is effective in treating exocrine pancreatic insufficiency in children with CF to help maintain adequate nutrition and normal growth," said Gavin Graff M.D.
While CREONŽ is already FDA-approved and indicated for the treatment of EPI due to CF and other conditions in patients ages zero and above, Solvay Pharmaceuticals is committed to the continued clinical study and development of CREONŽ as further confirmation of the safety and efficacy of pancreatic enzyme replacement therapies (PERTs) as described in medical literature and through clinical experience.
The safety and efficacy of PERTs with different formulations of pancrelipase consisting of the same active ingredient as CREONŽ (lipases, proteases, and amylases) for treatment of children with exocrine pancreatic insufficiency due to cystic fibrosis have been described in the medical literature and through clinical experience. There is a history of using different formulations of CREONŽ to treat pediatric patients with EPI due to CF, which has demonstrated efficacy and safety in those patients through years of clinical experience.
In addition to the supplemental CREONŽ pediatric data, data which supported the recent FDA approval of CREONŽ are also being presented at NACFC in a poster authored by Dr. Bruce Trapnell, entitled Pancrelipase delayed-release capsules (CREONŽ) in patients with pancreatic insufficiency due to cystic fibrosis: Age and severity analyses, during the general poster sessions.
Pediatric Study Details
The double-blind, randomized, multi-center, placebo-controlled, cross-over study examined the efficacy and safety of CREONŽ (pancrelipase) Delayed-Release 12,000 lipase unit capsules in 16 subjects ages 7-11 years with EPI due to CF. EPI was confirmed in all subjects by a CFA of <70% without pancreatic enzyme supplementation or pancreatic elastase <50 micrograms/gram stool within 12 months prior to start of study.
Upon analysis of the primary efficacy results, the mean CFA was greater during treatment with CREONŽ (82.8%) compared to treatment with placebo (47.4%), which resulted in a significant difference of 35.4% (p < 0.001). Thus, the study met its primary objective and showed a superior efficacy of CREONŽ over placebo based on the CFA. Treatment-emergent adverse events, which were predominantly gastrointestinal events, were reported in five patients during treatment with CREONŽ and nine patients during treatment with placebo.
About Exocrine Pancreatic Insufficiency and Pancreatic Enzyme Replacement Therapies
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.
SOURCE Solvay Pharmaceuticals, Inc.
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