PMID- 26728648
OWN - NLM
STAT- MEDLINE
DCOM- 20160303
LR  - 20220317
IS  - 1551-7489 (Print)
IS  - 1551-7489 (Linking)
VI  - 11
IP  - 6
DP  - 2015 Nov-Dec
TI  - Efficacy and safety of a hydrocodone extended-release tablet formulated with 
      abuse-deterrence technology in patients with moderate-to-severe chronic low back 
      pain.
PG  - 507-18
LID - jom.2015.0304 [pii]
LID - 10.5055/jom.2015.0304 [doi]
AB  - OBJECTIVE: To evaluate efficacy and safety of hydrocodone bitartrate extended 
      release (ER) tablets developed with CIMA((R)) Abuse-Deterrence Technology (ADT) 
      versus placebo in alleviating moderate-to-severe pain in patients with chronic 
      low back pain. DESIGN: 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). SETTING: Seventy-eight US centers. 
      MAIN OUTCOME MEASURES: 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.
FAU - Hale, Martin E
AU  - Hale ME
AD  - Medical Director, Gold Coast Research, LLC, Plantation, Florida.
FAU - Zimmerman, Thomas R
AU  - Zimmerman TR
AD  - Consultant to Teva Pharmaceuticals, Frazer, Pennsylvania.
FAU - Eyal, Eli
AU  - Eyal E
AD  - Teva Pharmaceuticals, Netanya, Israel.
FAU - Malamut, Richard
AU  - Malamut R
AD  - Teva Pharmaceuticals, Frazer, Pennsylvania.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Opioid Manag
JT  - Journal of opioid management
JID - 101234523
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Tablets)
RN  - 6YKS4Y3WQ7 (Hydrocodone)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Analgesics, Opioid/*administration & dosage
MH  - Chronic Pain/*drug therapy
MH  - Delayed-Action Preparations
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hydrocodone/*administration & dosage/adverse effects
MH  - Low Back Pain/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Opioid-Related Disorders/*prevention & control
MH  - Tablets
EDAT- 2016/01/06 06:00
MHDA- 2016/03/05 06:00
CRDT- 2016/01/06 06:00
PHST- 2016/01/06 06:00 [entrez]
PHST- 2016/01/06 06:00 [pubmed]
PHST- 2016/03/05 06:00 [medline]
AID - jom.2015.0304 [pii]
AID - 10.5055/jom.2015.0304 [doi]
PST - ppublish
SO  - J Opioid Manag. 2015 Nov-Dec;11(6):507-18. doi: 10.5055/jom.2015.0304.