⁃ Adult patients of age 18 or older, able to provide informed consent and follow all study procedures.

⁃ 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).

⁃ Score of equal or greater 0.6 on the EPI symptom tracker at baseline Visit 2.

⁃ Must be off PERT (including prescription and non-prescription enzymes) for 7 days prior to baseline Visit 2.

⁃ Must have fully completed the terminal intervention for necrotizing pancreatitis (surgical or endoscopic necrosectomy or percutaneous drainage).

⁃ Have a Body Weight between 40 and 120 kg (amounts to 600-1800 LU/meal pancrelipase starting dose of pancrelipase).

⁃ 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.

⁃ 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.