PANCREAZE is proven to improve
EPI symptoms14

PANCREAZE is a prescription medication that treats EPI (Exocrine Pancreatic Insufficiency) — a condition characterized by deficiency of the exocrine pancreatic enzymes (lipase, protease and amylase), resulting in maldigestion of food.15

In clinical studies, PANCREAZE is proven to improve EPI symptoms (i.e.: abdominal pain, bloating, diarrhea, greasy stools) vs. placebo.

EPI Symptom Assessments chart EPI Symptom Assessments chart

PANCREAZE is clinically proven
to improve fat and protein absorption1,14

Mean CFA and CNA Improvements (%) chart Mean CFA and CNA Improvements (%) chart

Study Design14

  • Randomized, double-blind, placebo-controlled study of 40 patients, ages 8 to 57 years, with EPI due to CF.
  • The study consisted of a 7-day screening phase, ≤14-day open-label run-in phase, and ≤7-day placebo controlled, double-blind, withdrawal phase. The duration of the double-blind phase ranged from 4 to 7 days, depending on patients’ gastrointestinal transit time. During the double-blind phase, participants with a CFA ≥80% were randomized (1:1) to continue their optimized dose of PANCREAZE (10.5 or 21) or switched to placebo.
  • The primary efficacy endpoint was change in percent CFA between the 72-hour stool collections at the end of the open-label phase and double-blind phase. A key secondary variable was change in coefficient of nitrogen absorption (CNA), a surrogate for protein absorption, from the open-label phase to the double-blind phase. Another key secondary variable was prevention of the clinical signs and symptoms of EPI (abdominal pain, bloating, diarrhea, greasy stools, vomiting) during the double-blind phase.

Primary and key secondary efficacy assessments of the study participants14

Primary and key secondary efficacy assessments of the study participants chart Primary and key secondary efficacy assessments of the study participants chart