Open AccessSingle‐Entity Hydrocodone Extended‐Release Capsules in Opioid‐Tolerant Subjects with Moderate‐to‐Severe Chronic Low Back Pain: A Randomized Double‐Blind, Placebo‐Controlled Study
Author(s) -
Rauck Richard L.,
Nalamachu Srinivas,
Wild James E.,
Walker George S.,
Robinson Cynthia Y.,
Davis Charles S.,
Farr Stephen J.
Publication year - 2014
Publication title -
pain medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.893
H-Index - 97
eISSN - 1526-4637
pISSN - 1526-2375
DOI - 10.1111/pme.12377
Subject(s) - medicine , placebo , hydrocodone , anesthesia , adverse effect , extended release , acetaminophen , randomized controlled trial , opioid , chronic pain , clinical endpoint , oxycodone , physical therapy , pharmacology , alternative medicine , receptor , pathology
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 (20−100 mg 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 ( S ubject G lobal A ssessment of M edication) 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 S ubject G lobal A ssessment of M edication 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.