Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency

Inclusion Criteria

• •1. Adult patients of age 18 or older, able to provide informed consent and follow all study procedures.
• •2. Stable outpatient up to 12 months following an acute pancreatitis episode and has EPI based on an FE-1 \< 200 µg/g stool obtained within 3 months prior to baseline assessment (Visit 2).
• •3. Score of equal or greater 0.6 on the EPI symptom tracker at baseline Visit 2.
• •4. Must be off PERT (including prescription and non-prescription enzymes) for 7 days prior to baseline Visit 2.
• •5. Must have fully completed the terminal intervention for necrotizing pancreatitis (surgical or endoscopic necrosectomy or percutaneous drainage).
• •6. Have a Body Weight between 40 and 120 kg (amounts to 600-1800 LU/meal pancrelipase starting dose of pancrelipase).
• •7. Women of childbearing potential must have a negative urine pregnancy test at Study Day 1 and practicing at least one protocol specified method of birth control (Section 5.2.4), starting at Study Day 1 through 30 days after last dose of pancrelipase.
• •8. Females of non-childbearing potential (either postmenopausal or permanently surgically sterile as defined:
• •* Age \> 55 years with no menses for 12 or more months without an alternative medical cause.
• •* Age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level \> 40 IU/L.
• •OR
• •Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
• •do not require pregnancy testing.