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Video: CREON(R) (Pancrelipase) Delayed-Release Capsules First and Only Pancreatic Enzyme Product to Receive FDA Approval Under New Guidelines
Date:5/1/2009

food. For patients with EPI, pancreatic enzymes are essential to ensure adequate nutrition and health. Pancreatic enzyme products 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 patients. 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 NDAs for all pancreatic enzyme products in order to remain on the market. By April 2010, all pancreatic enzymes are required to have approved NDAs and must be manufactured under the new guidelines.

Important Safety Information about FDA-Approved CREON(R)

In the clinical study used to demonstrate the efficacy and safety of FDA-approved CREON(R), the incidence of adverse events (regardless of causality) was higher during placebo treatment (71%) than during CREON(R) treatment (50%). Treatment-emergent adverse events occurring in at least two patients (greater than or equal to 6%) receiving CREON(R) or placebo were abdominal pain, abdominal pain upper, abnormal feces, cough, dizziness, flatulence, headache, and weight decreased.

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 whe
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SOURCE Solvay Pharmaceuticals
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