Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.

An Open-Label, Ascending, Two-Part, Single- and Multiple-Dose Evaluation of the Safety, Pharmacokinetics, and Effectiveness of Oxymorphone for Acute Postoperatiave Pain in Pediatric Subjects

When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40).

This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.

Inclusion Criteria:

• Male or female > 12 to 17 years of age, inclusive
• Weigh at least 50 kg
• Postoperative oral opioid analgesia required for at least 24 hours or 48 hours following postoperataive parenteral analgesia
• Are expected to be hospitalized for the duration of the study

Exclusion Criteria:

• Known allergy to, or a significant reaction to, oxymorphone or another opioid
• Life expectancy of < 4 weeks
• Positive pregnancy test at screening