Safety, tolerability, and effectiveness of oxymorphone extended release for moderate to severe osteoarthritis pain: a one-year study.

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.

• Authors: Harris McIlwain, Harry Ahdieh
• Journal: American journal of therapeutics (Am J Ther) 2005 Mar-Apr Vol. 12 Issue 2 Pg. 106-12 ISSN: 1075-2765 [Print] United States
• PMID: 15767827 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics, Opioid
• Delayed-Action Preparations
• Oxymorphone

Topics

• Analgesics, Opioid (administration & dosage, adverse effects, therapeutic use)
• Chronic Disease
• Delayed-Action Preparations
• Female
• Humans
• Male
• Middle Aged
• Osteoarthritis (complications)
• Oxymorphone (administration & dosage, adverse effects, therapeutic use)
• Pain (drug therapy, etiology)
• Pain Measurement