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 > or =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.