FDA Approved Drugs » 2012
Medical Areas: Endocrinology | Gastroenterology | Hepatology (Liver, Pancreatic, Gall Bladder) | Genetic Disease
View By:Year | Company | Conditions | Therapeutic Areas | Drug Names
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Aptalis Pharma
Approval Status: Approved March 2012
Treatment Area: exocrine pancreatic insufficiency
Ultresa (pancrelipase) delayed-release capsules is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, amylases, and proteases. The pancreatic enzymes in Ultresa act like digestive enzymes physiologically secreted by the pancreas.
Ultresa is specifically indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
Ultresa is supplied as a tablet for oral administration. The initial dose of Ultresa should begin at the lowest recommended dose and gradually increased. The dosage of Ultresa should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.
FDA ApprovalThe FDA approval of Ultresa was based on two clinical trials conducted in 40 subjects, ages 7 to 37 years, with exocrine pancreatic insufficiency associated with cystic fibrosis.Study OneThis randomized, double-blind, placebo-controlled, crossover study enrolled 31 subjects ages 8 to 37 years. The subjects were randomized to receive Ultresa at a dose not to exceed 2,500 lipase units per kilogram per meal or snack or matching placebo for 6 to 7 days of treatment followed by crossover to the alternate treatment for an additional 6 to 7 days. All subjects consumed a high-fat diet (2 grams of fat per kilogram of body weight per day) during the treatment periods. The final analysis population was limited to 24 subjects who completed both treatment periods and had stool results available for each treatment period.The primary endpoints were the coefficient of fat absorption (CFA) and the coefficient of nitrogen absorption (CNA), both determined by a 72-hour stool collection during both treatments. The Mean CFA was 89% with Ultresa treatment compared to 56% with placebo treatment. The mean difference in CFA was 35 percentage points in favor of Ultresa (p<0.0001). The mean CNA was 84% with Ultresa treatment compared to 59% with placebo treatment. The mean difference in CNA was 26 percentage points in favor of Ultresa treatment (p<0.0001).Study TwoThis open-label study enrolled 9 subjects, ages 7 years to 11 years. After a 15 day screening period on individually-titrated doses of Ultresa not exceeding 2,500 lipase units per kilogram per meal, the subjects entered a 7-day washout phase before returning to a 12-day treatment phase on the same individually-titrated dose of Ultresa. The mean daily dose of Ultresa during the treatment phase was 6,846 lipase units per kilogram body weight per day. All subjects consumed a high-fat diet (2 grams of fat per kilogram of body weight per day) during both the washout phase and the treatment phase. The final analysis was limited to 7 subjects who completed both the washout and treatment phases of the study. The mean CFA was 35% during the washout phase and was 83% during the Ultresa treatment phase.
Adverse reactions associated with the use of Ultresa may include, but are not limited to, the following:
Ultresa (pancrelipase) delayed-release capsules is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. The pancreatic enzymes in Ultresa catalyze the hydrolysis of fats to monoglycerides, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltotriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.
For additional information regarding Viokace or exocrine pancreatic insufficiency due to cystic fibrosis or other conditions, please visit the AptalisPharma web page.
Unless otherwise specified, all medical content is compiled by MSF staff and reviewed for accuracy by a member of our Medical Advisory Board.
The MSF strives to present clear and unbiased information. This site is partially funded through a grant from Bayer Healthcare, LLC.
© Copyright 2000-2009 Multiple Sclerosis Foundation - All Rights Reserved