Safety, Tolerability, Effectiveness, and Pharmacokinetic Data in Opioid-experienced Children

Inclusion Criteria:

1. Were males or females 7 - ≤17 years of age. Females of childbearing potential had tobe practicing abstinence or using a medically acceptable form of contraception (eg,intrauterine device, hormonal birth control, or double barrier method). For thepurpose of this study, all menstruating females were considered to be of childbearingpotential unless they were biologically sterile or surgically sterile for more than 1year.
2. Had chronic pain (malignant and/or nonmalignant) or postsurgical pain expected torequire ATC opioid analgesia for up to 12 weeks with at least 10 mg per dayoxymorphone ER (approximately equal to 30 mg per day oral MSE).
3. Had a body weight at least 18 kg.
4. Were able to swallow oxymorphone ER tablets.
5. Had laboratory results from within 21 days prior to Baseline available includingclinical chemistry and hematology laboratory analytes. Intraoperative (prior tosurgical incision) labs were acceptable provided the results had been reviewed by theinvestigator for study eligibility prior to dosing.
6. Subjects with postsurgical pain were prescribed a parenteral analgesic regimenutilizing a short-acting opioid analgesic AND were anticipated to be switched to anoral opioid for an extended period of time (according to institutions standard ofcare).
7. Were able to provide pain assessment evaluations using age-appropriate instrumentsprovided in the protocol.
8. Had been informed of the nature of the study and informed consent and assent (asappropriate) have been obtained from the legally responsible parent(s)/legalguardian(s) and subject, respectively, in accordance with IRB requirements. To participate in the PK Period, subjects had:
9. Been hospital inpatients, expected to be hospitalized for up to 72 hours following theinitial administration of oxymorphone ER.
10. An indwelling access catheter in place for blood sampling.

Exclusion Criteria:

1. Had known allergies or sensitivities to oxymorphone or other opioid analgesics.
2. Had a known sensitivity to any component of the oxymorphone ER.
3. Had a life expectancy <3 months.
4. Was pregnant and/or lactating.
5. Had cyanotic heart disease.
6. Had respiratory, hepatic, renal, neurological, psychological disease, or any otherclinically significant condition that would, in the Investigator's opinion, precludeparticipation in the study.
7. Had abdominal trauma that would interfere with absorption of oxymorphone ER.
8. Had increased intracranial pressure.
9. Had a respiratory condition requiring intubation.
10. Had a history of uncontrolled seizures that were not managed with anticonvulsants.
11. Had prior history of substance abuse or alcohol abuse.
12. Had taken a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start ofoxymorphone ER.
13. Had taken oxycodone or oxymorphone within 48 hours prior to Baseline.
14. The investigator anticipated that the subject and/or parent(s)/legal guardian(s) wasunable to comply with the protocol.
15. The subject (and/or parent[s]/legal guardian[s]) was (were) unable to communicateeffectively with study personnel.