It was previously demonstrated that oxymorphone extended release (OPANA® ER) is safe and effective for treating chronic low back pain in opioid-naive patients. This subanalysis of a multicenter, enriched-enrollment, randomized-withdrawal trial evaluated the safety and efficacy of oxymorphone ER in opioid-naive patients with primary diagnosis of degenerative disc disease (DDD). During the enrichment phase, patients received open-label 5-mg oxymorphone ER q12h for 2 days and then were titrated (increments of 5-10 mg every 3–7 d) to a stabilized dose providing adequate and tolerable analgesia (average pain intensity ≤40 mm on 100-mm Visual Analog Scale [VAS]). 107 patients entered titration; 62 (57.9%) were stabilized (median dose 40 mg). 16 (15.0%) discontinued due to an adverse event (AE). During the 12-week, double-blind, randomized phase, patients received their stabilized dose of oxymorphone ER (n = 34) or placebo (n = 28); 18 (52.9%) and 13 (46.4%), respectively, completed treatment. From baseline to final visit, the mean increase in VAS pain intensity was significantly (P < 0.001) greater in placebo group (35.0 ± 4.4) than in oxymorphone group (12.7 ± 3.9). 4 oxymorphone ER patients (11.8%) and 1 placebo patient (3.6%) discontinued due to an AE. The most frequent treatment-emergent AEs were nausea (4.7% [n = 5/107]), constipation (3.8% [n = 4/107]), and vomiting (3.8% [n = 4/107]) with oxymorphone ER and nausea, diarrhea, and upper respiratory tract infection (each 1.9% [n = 2/107]) with placebo. In this study, approximating conditions encountered by treating physicians, titration of oxymorphone ER was generally well tolerated and successful for most opioid-naive patients with DDD. Oxymorphone ER was efficacious, with a low AE rate. It was previously demonstrated that oxymorphone extended release (OPANA® ER) is safe and effective for treating chronic low back pain in opioid-naive patients. This subanalysis of a multicenter, enriched-enrollment, randomized-withdrawal trial evaluated the safety and efficacy of oxymorphone ER in opioid-naive patients with primary diagnosis of degenerative disc disease (DDD). During the enrichment phase, patients received open-label 5-mg oxymorphone ER q12h for 2 days and then were titrated (increments of 5-10 mg every 3–7 d) to a stabilized dose providing adequate and tolerable analgesia (average pain intensity ≤40 mm on 100-mm Visual Analog Scale [VAS]). 107 patients entered titration; 62 (57.9%) were stabilized (median dose 40 mg). 16 (15.0%) discontinued due to an adverse event (AE). During the 12-week, double-blind, randomized phase, patients received their stabilized dose of oxymorphone ER (n = 34) or placebo (n = 28); 18 (52.9%) and 13 (46.4%), respectively, completed treatment. From baseline to final visit, the mean increase in VAS pain intensity was significantly (P < 0.001) greater in placebo group (35.0 ± 4.4) than in oxymorphone group (12.7 ± 3.9). 4 oxymorphone ER patients (11.8%) and 1 placebo patient (3.6%) discontinued due to an AE. The most frequent treatment-emergent AEs were nausea (4.7% [n = 5/107]), constipation (3.8% [n = 4/107]), and vomiting (3.8% [n = 4/107]) with oxymorphone ER and nausea, diarrhea, and upper respiratory tract infection (each 1.9% [n = 2/107]) with placebo. In this study, approximating conditions encountered by treating physicians, titration of oxymorphone ER was generally well tolerated and successful for most opioid-naive patients with DDD. Oxymorphone ER was efficacious, with a low AE rate.
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