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

• Published in: Pain medicine (Malden, Mass.) Vol. 15; no. 6; pp. 975 - 985
• Main Authors: Rauck, Richard L., Nalamachu, Srinivas, Wild, James E., Walker, George S., Robinson, Cynthia Y., Davis, Charles S., Farr, Stephen J.
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 01.06.2014
• Subjects: Adolescent; Adult; Aged; Analgesics, Opioid - administration & dosage; Back pain; Chronic Pain; Chronic Pain - diagnosis; Chronic Pain - drug therapy; Delayed-Action Preparations - administration & dosage; Double-Blind Method; Drug therapy; Drug Tolerance; Extended Release; Female; Humans; Hydrocodone; Hydrocodone - administration & dosage; Low Back Pain - diagnosis; Low Back Pain - drug therapy; Male; Middle Aged; Opioids; Pain Measurement - drug effects; Pain Measurement - methods; Randomized Controlled Trial; Severity of Illness Index; Young Adult; Extended Release; Randomized Controlled Trial; Hydrocodone; Opioids; Chronic Pain
• ISSN: 1526-2375; 1526-4637; 1526-4637
• DOI: 10.1111/pme.12377

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 (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.