2 dosage strengths available1

Significant improvement in fat absorption1

* A multicenter, randomized, parallel-group, placebo-controlled, double-blind study of 50 patients, ages 24 to 70 years, with EPI due to chronic pancreatitis or pancreatectomy. Eighteen patients had a history of pancreatectomy (11 were treated with VIOKACE). After a wash-out period (6-7 days), patients were randomized to a fixed dose of VIOKACE, 22 tablets per day (6 tablets with 3 meals and 2 tablets with 2 or 3 snacks) or placebo, in combination with a proton pump inhibitor. Duration of exposure ranged from 6 to 7 days. All patients were maintained on a controlled high-fat diet of 100 grams of fat per day. Forty-nine patients completed the double-blind period. The CFA was determined by a 72-hour stool collection during both treatments, when both fat excretion and fat ingestion were measured. The wash-out period mean CFA was 48% in the VIOKACE treatment group and 57% in the placebo group. The mean difference in CFA at the end of the double-blind treatment period was 28 percentage points in favor of VIOKACE treatment with 95% Confidence Interval (21,37) and P≤.0001.1

Established tolerability in adults with EPI1