An Open-Label, Non-randomized, Multicenter, Ascending Dose by Age, Single- and Multiple-Dose Evaluation of the Effectiveness, Safety, and Tolerability of Oral Liquid Oxymorphone HCl Immediate-Release Oral Liquid for Acute Postoperative Pain in Pediatric Subjects

The purpose of this study is to evaluate the effectiveness, tolerability, and safety of
oxymorphone immediate release (IR) oral liquid as an analgesic for acute postoperative pain
in pediatric subjects.

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

本研究旨在评估羟吗啡酮速释（immediate release, IR）口服液作为儿科受试者急性术后疼痛镇痛药的有效性、耐受性与安全性。本项上市后研究由美国食品药品监督管理局（FDA）要求开展。恩多制药公司（Endo Pharmaceuticals Inc.）现已不再推广阿片类药物，亦不再销售奥巴纳®缓释制剂（Opana® ER）。