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Research

FDA Approved Drugs » 2012
Medical Areas: Endocrinology | Gastroenterology | Family Medicine | Hepatology (Liver, Pancreatic, Gall Bladder)

View By:Year | Company | Conditions | Therapeutic Areas | Drug Names

Viokace (pancrelipase) tablets

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:

General Information

Viokace (pancrelipase) is a pancreatic enzyme preparation for oral administration 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 Viokace act like digestive enzymes physiologically secreted by the pancreas.

Viokace is speicifcally approved in combination with a proton pump inhibitor for adults with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy.

Viokace is supplied as a tablet for oral administration. Since Viokace is not enteric-coated, it should be taken in combination with a proton pump inhibitor. Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of Viokace should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.

Clinical Results

FDA Approval
The FDA approval of Viokace was based on a randomized, double-blind, placebo-controlled, parallel group study in 50 subjects ages 24 to 70, with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy. After a wash-out period of six to 7 days, subjects were randomized to a fixed dose of Viokace (22 tablets per day; six tablets per meal and two tablets with two of three snacks; (20,880 USP units of lipase per tablet)) or placebo, in combination with a proton pump inhibitor. All subjects were maintained on a controlled high fat diet of 100 grams of fat per day. The coefficient of fat absorption (CFA) was determined by a 72-hour stool collection during both treatments. The wash-out period mean CFA was 48% in the Viokace treatment group and was 57% in the placebo group. At the end of the double-blind treatment period, the mean CFA was 86% with Viokace treatment compared to 58% with placebo. The mean difference in CFA at the end of the double-blind treatment period was 28 percentage points in favor of Viokace (p < 0.0001).

Side Effects

Adverse events associated with the treatment of Viokace may include, but are not limited to, the following:

  • biliary tract stones
  • anal pruritus

Mechanism of Action

Viokace (pancrelipase) is a pancreatic enzyme preparation for oral administration 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 Viokace 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 maltriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.

Additional Information

For additional information regarding Viokace or exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy, please visit the AptalisPharma web page.

 
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