This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Web of Science (14) Citing Articles via Google Scholar Google Scholar Articles by Gimbel, J. Articles by Ahdieh, H. Search for Related Content PubMed PubMed Citation Articles by Gimbel, J. Articles by Ahdieh, H. Related Collections Postanesthetic Care Unit Pain Pharmacology

---

PAIN MEDICINE

The Efficacy and Safety of Oral Immediate-Release Oxymorphone for Postsurgical Pain

Joseph Gimbel, MD^*, and Harry Ahdieh, PhD

*Arizona Research Center, Phoenix, Arizona; and Endo Pharmaceuticals Inc., Chadds Ford, Pennsylvania

Address correspondence and reprint requests to Joseph Gimbel, MD, Medical Director, Arizona Research Center, 2525 W. Greenway Rd., Ste. 114, Phoenix, AZ 85023. Address e-mail to Azresearch{at}aol.com

In this double-blind, parallel-group study, we compared 3 oxymorphone immediate-release (IR) doses with placebo for efficacy and with oxycodone IR and placebo for safety in patients with acute moderate-to-severe postsurgical pain. During the single-dose phase (n = 300), patients received oxymorphone IR 10, 20, or 30 mg; oxycodone IR 10 mg; or placebo. All oxymorphone IR doses were superior for providing pain relief for 8 h (P < 0.05), with a significant analgesic dose response (P < 0.001). Significant pain intensity differences occurred by 45 min (20- and 30-mg doses; P < 0.05). Discontinuations for lack of efficacy totaled 42% among placebo-treated patients and 27% among those treated with oxymorphone IR. Patients requiring rescue medication after 3 h were allowed to receive additional study drug every 4 to 6 h as needed for the multiple-dose phase (n = 164). All oxymorphone groups maintained analgesia for 48 h. The median dosing interval was >9.5 h for oxymorphone IR 30 mg and 7 h for the other groups. Opioid-related adverse events, similar among groups, were generally mild or moderate. Oxymorphone IR 10, 20, or 30 mg provided significant dose-related pain relief compared with placebo, and this relief was maintained over several days with a safety profile comparable to that of oxycodone IR.

IMPLICATIONS: Oxymorphone immediate-release provides effective pain relief in patients experiencing moderate-to-severe pain after major orthopedic surgery.

This article has been cited by other articles:

				C. E. Argoff and D. I. Silvershein A Comparison of Long- and Short-Acting Opioids for the Treatment of Chronic Noncancer Pain: Tailoring Therapy to Meet Patient Needs Mayo Clin. Proc., July 1, 2009; 84(7): 602 - 612. [Abstract] [Full Text] [PDF]

				K. W Chamberlin, M. Cottle, R. Neville, and J. Tan Oral Oxymorphone for Pain Management Ann. Pharmacother., July 1, 2007; 41(7): 1144 - 1152. [Abstract] [Full Text] [PDF]

				R. Sinatra Opioid Analgesics in Primary Care: Challenges and New Advances in the Management of Noncancer Pain J Am Board Fam Med, March 1, 2006; 19(2): 165 - 177. [Abstract] [Full Text] [PDF]