Drug intelligence / Profile preview

Viokase 16 + placebo

Development stage
Unknown
Lead developer
Allergan
Modality
Replacement Enzymes → Therapeutic Enzymes → Recombinant Proteins and Enzymes
Administration
Oral
01

Overview

Viokase 16 is a non-enteric coated, immediate-release pancreatic enzyme replacement therapy (PERT) derived from porcine pancreatic tissue. It contains a combination of lipase, amylase, and protease. In the context of the University of Florida clinical trial (NCT01142128), this specific intervention arm (Viokase 16 + placebo) was used to evaluate the efficacy of pancrelipase alone (without a proton pump inhibitor) in reducing chronic abdominal pain in patients with small duct chronic pancreatitis. The therapeutic rationale for using PERT in chronic pancreatitis pain involves the intraduodenal proteases providing negative feedback to the pancreas, thereby reducing pancreatic secretion and intraductal pressure. Because Viokase 16 is not enteric-coated, it is susceptible to gastric acid degradation, which is why it is typically administered with a PPI, though this arm specifically omitted the PPI to serve as a comparator.

Brand names
Viokace
Other names
pancrelipasepancreatic enzymes
02

Targets

CTRC (Chymotrypsin C)PNLIP (Pancreatic triacylglycerol lipase)AMY (Pancreatic alpha-amylase)PRSS1 (Trypsin family)

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