A Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Investigational Product MP-101 in Subjects With Short Bowel Syndrome Who Have Had an Inadequate Response to Anti-Diarrheals

Inclusion Criteria:

1. Be male or female adults, 18 years of age or older at the time of consent

2. Have SBS that is inadequately controlled on current antidiarrheal medication (e.g.,
loperamide or diphenoxylate), including subjects with ileostomies, based on the 7
days prior to Day 1 of the study

a. Subjects must be >3months post intestinal resection

3. Have a history of persistent loose stools for more than 4 weeks

4. Be on a combination of Opium Tincture and an anti-diarrheal (loperamide or
diphenoxylate) or an anti-diarrheal agent alone

5. If currently taking Opium Tincture, be willing to stop the continued use of Opium
Tincture at screening visit until the start of study treatment and willing to stop
the use of any other anti-diarrheal for the duration of the study

6. Be able to maintain their current diet for the duration of the study

7. Be on stable nutritional support (parenteral or oral)

8. Males or non-pregnant, non-lactating females who are postmenopausal, naturally or
surgically sterile, or who agree to use effective contraceptive methods throughout
the course of the study. Postmenopausal is defined as at least 12 months of natural
spontaneous amenorrhea, or at least 6 weeks following surgical menopause (bilateral
oophorectomy)

9. Females of childbearing potential must agree to use 1 of the following acceptable
birth control methods:

1. Surgically sterile (hysterectomy or bilateral oophorectomy)

2. Surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior
to study initiation)

3. Intrauterine device (IUD) in place for at least 3 months

4. Abstinence (not having sexual intercourse)

5. Barrier method (condom or diaphragm) with spermicide for at least 14 days prior
to screening and through study completion

6. Stable hormonal contraceptive for at least 3 months prior to study and through
study completion

7. Vasectomized partner

10. Females of childbearing potential must have a negative serum human chorionic
gonadotropin (hCG) pregnancy test at screening

11. Be able to understand and provide signed informed consent

Exclusion Criteria:

1. Unable or unwilling to stop the use of Opium Tincture or any anti-diarrheal
medication at the screening visit.

2. Have any history of or active neurological, endocrine, cardiovascular, pulmonary,
hematological, immunologic, psychiatric, or metabolic disease that is considered
clinically significant, is not currently controlled by medication, and is stable as
deemed by the Investigator

3. Have clinically significant electrocardiogram (ECG) abnormalities as determined by
the PI or vital sign abnormalities (systolic blood pressure < 90 mmHg, diastolic
blood pressure < 60 mmHg, or heart rate >100 bpm) at screening

4. Have clinically significant elevation of liver enzymes (> 3 times the upper limit of
normal) or clinically relevant renal disease, (creatinine >1.5) or any other
clinically significant abnormal laboratory test results found during medical
screening as determined by the Principal Investigator

5. Have a history of major mental illness that in the opinion of the Investigator may
affect the ability of the subject to safely participate and reliably complete the
study

6. Have a history of alcohol or substance abuse within the past 2 years. Alcohol abuse
will be defined as >14 drinks per week (1 drink = 12 oz. beer, 5.0 oz. wine, or 1.5
oz. distilled spirits)

7. Have a known allergy or intolerance to Opium Tincture or any of the excipients in the
formulation (alcohol, opium, or morphine)

8. Is currently taking an opioid derivative (other than Opium Tincture) or any other
medication which, in the opinion of the investigator, could interfere with the
interpretation of the study results

9. Are currently taking antibiotics for bacterial overgrowth

10. Have participated in another interventional clinical trial within 30 days prior to
screening with the exception of observational cohort studies or non-interventional
studies.

11. Have known or suspected pregnancy, planned pregnancy, or lactation

12. Have a planned surgery over the course of the study

13. Have a condition the Investigator believes would interfere with the ability to
provide informed consent or comply with study instructions, or that might confound
the interpretation of the study results or put the subject at undue risk