title: 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 (20-100 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.
authors: Carolinas Pain Institute, Center for Clinical Research, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
authors: Richard L
authors: RL
authors: Rauck
authors: Srinivas
authors: S
authors: Nalamachu
authors: James E
authors: JE
authors: Wild
authors: George S
authors: GS
authors: Walker
authors: Cynthia Y
authors: CY
authors: Robinson
authors: Charles S
authors: CS
authors: Davis
authors: Stephen J
authors: SJ
authors: Farr
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D059350:Chronic Pain / Q000175:diagnosis / Q000188:drug therapy*; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004311:Double-Blind Method; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D006853:Hydrocodone / Q000008:administration & dosage*; D017116:Low Back Pain / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000187:drug effects / Q000379:methods; D012720:Severity of Illness Index; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D006853:Hydrocodone
keywords: Chronic Pain; Extended Release; Hydrocodone; Opioids; Randomized Controlled Trial