Original ArticlesSafety, Tolerability, and Effectiveness of Oxymorphone Extended Release for Moderate to Severe Osteoarthritis Pain A One-Year StudyMcIlwain, Harris1*; Ahdieh, Harry2 Author Information 1Tampa Medical Group Research, Tampa, Florida; and 2Endo Pharmaceuticals Inc., Chadds Ford, Pennsylvania. *Address for correspondence: Tampa Medical Group Research, 4700 N. Habana Avenue, Suite 303, Tampa, FL 33614. E-mail: [email protected] American Journal of Therapeutics: March 2005 - Volume 12 - Issue 2 - p 106-112 doi: 10.1097/01.mjt.0000139442.65914.f9 Buy Metrics Abstract A 52-week, multicenter, open-label extension study was performed to evaluate the safety, tolerability, and effectiveness of oxymorphone extended release (ER), a novel tablet formulation of oxymorphone hydrochloride, in 153 patients with moderate to severe chronic osteoarthritis-related pain. Sixty-one patients (39.9%) completed the study. Common opioid-related nonserious adverse events (AEs) caused most withdrawals. However, approximately one-half of withdrawals due to AEs were among opioid-naive patients who received placebo in a previous trial and were started on a dose of 20 mg every 12 hours, suggesting that tolerability can be improved by titrating from a lower initial dose. Mean pain scores initially decreased as previously opioid-naive patients achieved adequate pain relief, reached stable levels after the first 6 weeks, and remained stable at mild levels throughout the remainder of the study (average pain, 20-25 mm on 100-mm Visual Analog Scale). Average daily dosing remained stable throughout the study (median, 40 mg/d). At each assessment, at least 80% of patients rated their global satisfaction with oxymorphone ER as “excellent,” “very good,” or “good.” Oxymorphone ER provides a new 12-hour analgesic for the treatment of moderate to severe chronic osteoarthritis-related pain in patients who may require long-term opioid therapy. © 2005 Lippincott Williams & Wilkins, Inc.