Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects

Inclusion Criteria:

1. Is male or female <2 years of age at the time of surgery.

2. Must weigh at least 3 kg.

3. Is scheduled to have a surgical procedure for which opioid analgesia will be needed to
manage postoperative pain for at least 18 hours following intraoperative and/or
postoperative IV analgesia.

4. Is generally healthy as documented by medical history; physical examination
(including, but not limited to, the cardiovascular, gastrointestinal, respiratory, and
central nervous systems); vital sign assessments; 12-lead electrocardiograms (EKGs);
clinical laboratory assessments; and general observations. Any abnormalities or
deviations from the acceptable range that might be considered clinically relevant by
the study physician or investigator will be evaluated on a case-by-case basis, agreed
upon by the Principal Investigator (or sub-investigator), and documented in study
files before enrolling the subject in the study.

5. The subject's parent or guardian has been informed of the nature of the study and has
provided written informed consent.

Postoperative:

6. Is anticipated to require an analgesic regimen using a short-acting opioid
(non-oxycodone and non-oxymorphone) analgesic after surgery (according to standard of
care (SOC) as defined in the protocol).

7. Is an inpatient expected to be hospitalized for 24 hours after dosing with study drug.

8. Has an indwelling access catheter for blood sampling.

9. Has demonstrated the ability to tolerate clear fluids following surgery according to
the SOC at each institution. All infants and children should be able to demonstrate
strong suck and swallow reflexes and neurologic alertness and stability sufficient to
handle oral secretions. The ability to tolerate small amounts (1 to 2 oz.) of clear
liquids without emesis (over 30 to 60 minutes) would support readiness for study
participation and oral intake once the physician has ordered the diet advanced to
clear liquids and the subject has ingested fluids by mouth without nausea or vomiting.

Exclusion Criteria:

1. Has the presence or history of a clinically significant disorder involving the
cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic,
endocrine, or nervous system(s) or psychiatric disease that would contraindicate
participation, as determined by the Investigator.

2. Has any clinical laboratory test result outside the accepted range that has been
confirmed upon re-examination and deemed to be clinically significant.

3. Has a clinically significant illness or condition any time before dosing with study
drug that would contraindicate participation, as determined by the Investigator.

4. Has a life expectancy <8 weeks.

5. For age groups A and B: Has a malabsorption, gastroenterologic, or abdominal condition
that would interfere with the absorption of study drug.

6. Has evidence of increased intracranial pressure.

7. Has a respiratory condition requiring intubation or resulting in active bronchiolitis,
asthma, stridor, or difficulty breathing due to congestion and increased nasal
secretions, including oxygen (O2) saturation ≤92%.

8. Has a history of seizures.

9. Subject (and/or mother if subject is nursing) has used medications with actions
characteristic of monoamine oxidase inhibitors (MAOIs) within 14 days before the start
of the study drug is prohibited. Standard daily pediatric multivitamins may be taken
until enrollment into the study but will be restricted during the study.

10. Subject (and/or mother if subject is nursing) has received preoperative opioids for
more than 72 consecutive hours.

11. Subject (and/or mother if subject is nursing) has received oxycodone or oxymorphone
within 48 hours prior to screening.

12. Subject (and/or mother if subject is nursing) has ingested caffeine- or
xanthine-containing products (eg, theophylline) within 48 hours before dosing. These
products are also prohibited during periods when blood samples are collected.

13. Has a history of relevant drug allergies, food allergies, or both (ie, allergy to
oxymorphone or other opioid analgesics) that could interfere with the study.

14. Parent or legal guardian is unable to provide consent for any reason (eg, mental or
physical disabilities, language barriers, or is unavailable).

15. Subject (and/or mother if subject is nursing) has participated in a clinical study of
an unapproved drug within the previous 30 days.

16. Is not suitable for entry into the study in the opinion of the Investigator.