title: Efficacy and safety of a hydrocodone extended-release tablet formulated with abuse-deterrence technology in patients with moderate-to-severe chronic low back pain.
abstract: OBJECTIVE
  To evaluate efficacy and safety of hydrocodone bitartrate extended release (ER) tablets developed with CIMA(®) Abuse-Deterrence Technology (ADT) versus placebo in alleviating moderate-to-severe pain in patients with chronic low back pain.
  
  
  METHODS
  Phase 3, randomized, double-blind study consisting of a screening period (7-14 days), open-label titration period (≤ 6 weeks), and double-blind treatment period (≤ 12 weeks).
  
  
  METHODS
  Seventy-eight US centers.
  
  
  METHODS
  Changes from baseline at week 12 in weekly average of daily worst pain intensity (WPI; primary efficacy measure), weekly average pain intensity (API; secondary efficacy measure), adverse events (AEs), and study drug loss and diversion.
  
  
  RESULTS
  Patients (N = 625) who entered open-label dose titration and identified the analgesic hydrocodone ER dose (30-90 mg every 12 h) providing optimal pain relief with minimal AEs were randomized to hydrocodone ER (n = 191) or placebo (n = 180) for double-blind treatment at the identified dose; 297 patients completed the study. Least squares means [SE] changes from baseline were significantly greater (worsening pain; 11-point scale) with placebo than hydrocodone ER in weekly average of daily WPI (0.74 [0.15] vs 0.11 [0.14]; p < 0.001) and weekly API (0.55 [0.14] vs -0.03 [0.12]; p < 0.001). The most common AEs with hydrocodone ER were constipation (14 percent) and nausea (10 percent). Study drug loss (≤ 4 percent) and diversion (≤ 2 percent) rates were low.
  
  
  CONCLUSIONS
  Hydrocodone ER formulated with ADT was significantly more effective than placebo in alleviating chronic low back pain and demonstrated a safety profile consistent with that of opioids, with a low occurrence of study drug loss and diversion.
authors.affiliation: Medical Director, Gold Coast Research, LLC, Plantation, Florida.
authors.forename: Martin E
authors.initials: ME
authors.lastname: Hale
authors.affiliation: Consultant to Teva Pharmaceuticals, Frazer, Pennsylvania.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Zimmerman
authors.affiliation: Teva Pharmaceuticals, Netanya, Israel.
authors.forename: Eli
authors.initials: E
authors.lastname: Eyal
authors.affiliation: Teva Pharmaceuticals, Frazer, Pennsylvania.
authors.forename: Richard
authors.initials: R
authors.lastname: Malamut
mesh_terms: D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D059350:Chronic Pain / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006853:Hydrocodone / Q000008:administration & dosage* / Q000009:adverse effects; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009293:Opioid-Related Disorders / Q000517:prevention & control*; D013607:Tablets
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D013607:Tablets; D006853:Hydrocodone