Single-entity hydrocodone extended-release capsules in opioid-tolerant subjects with moderate-to-severe chronic low back pain: A randomized double-blind, placebo-controlled study

Abstract

Objective: A single-agent, extended-release formulation of hydrocodone (HC) has been developed for treatment of chronic moderate-to-severe pain. This study was designed to examine the safety and efficacy of HC extended release in opioid-experienced adults with moderate-to-severe chronic low back pain (CLBP). Methods: This multicenter, enriched enrollment, randomized withdrawal study comprised an open-label conversion/titration phase (≤6 weeks) followed by placebo-controlled, double-blind treatment (12 weeks). During the conversion/titration phase, subjects (N=510) converted from their current opioid and were titrated to a stabilized dose of HC extended release (20-100mg every 12 hours). During treatment, subjects (N=151 per group) received HC extended release or placebo; rescue medication was permitted. The primary efficacy end point was mean change in average pain intensity from baseline to day 85. Response rates (30% pain improvement) and satisfaction (Subject Global Assessment of Medication) were assessed. Results: Demographic and baseline characteristics were similar between groups. Mean±SD change in average pain intensity score from baseline to day 85 was significantly lower in the HC extended-release treatment group vs placebo (0.48±1.56 vs 0.96±1.55; P=0.008). Significantly more responders were in the treatment group (68% vs 31%; P<0.001). Mean Subject Global Assessment of Medication scores increased significantly (0.8±1.3 vs 0.0±1.4; P<0.0001), indicating greater satisfaction with HC extended release. The adverse event profile was consistent with other opioids. Conclusions: Extended-release HC is well tolerated and effective, without acetaminophen-associated risks of liver toxicity, for treatment of CLBP. © 2014 American Academy of Pain Medicine.