AUSTIN, TX—Once-daily hydromorphone ER (OROS) and twice-daily oxycodone CR maintain efficacy through 52 weeks of follow-up for the treatment of chronic non-cancer pain, as demonstrated by clinical study data presented by Ute Richarz, MD, and colleagues from Global Medical Affairs Lead, Janssen-Cilag, Baar, Switzerland, at the American Pain Society’s 30th Annual Scientific Meeting.
Patients who had previously completed an open-label, randomized, 24-week, flexible-dose study evaluating the noninferiority of once-daily hydromorphone ER vs. oxycodone CR twice-daily for treatment of chronic non-cancer pain were enrolled in a 28-week, open-label, international, multicenter, randomized, comparative, parallel-group noninferiority extension study. A total of 112 patients were enrolled (60 hydromorphone ER, 52 oxycodone CR; mean age, 58.1 years; 54% female; 100% Caucasian). The primary efficacy measure in the extension phase was change in Brief Pain Inventory (BPI) “pain right now” assessed at Weeks 38 and 52. Secondary endpoints included global assessments of efficacy, dosing convenience, and tolerability.
Mean change in pain assessment from baseline to Week 38 was -3.0 for hydromorphone ER compared with -2.8 for oxycodone CR, and from baseline to Week 52, end of the extension phase, was -2.9 vs. -2.8, respectively. These changes in pain assessment were similar to those observed in the core phase of the study (-2.1 vs. -2.1 for OROS hydromorphone ER and oxycodone CR, respectively).