PMID- 27194199
OWN - NLM
STAT- MEDLINE
DCOM- 20160913
LR  - 20220317
IS  - 1551-7489 (Print)
IS  - 1551-7489 (Linking)
VI  - 12
IP  - 2
DP  - 2016 May-Jun
TI  - Six-month, open-label study of hydrocodone extended release formulated with 
      abuse-deterrence technology: Safety, maintenance of analgesia, and abuse 
      potential.
PG  - 139-47
LID - jom.2016.0326 [pii]
LID - 10.5055/jom.2016.0326 [doi]
AB  - OBJECTIVE: To evaluate long-term safety, maintenance of analgesia, and aberrant 
      drug-related behaviors of hydrocodone extended release (ER) formulated with CIMA(R) 
      Abuse-Deterrence Technology. DESIGN: Phase 3, multicenter, open-label extension. 
      SETTING: Fifty-six US centers. PATIENTS: Adults with chronic low back pain 
      completing a 12-week placebocontrolled study of abuse-deterrent hydrocodone ER 
      were eligible. One hundred eighty-two patients enrolled and received >/=1 dose of 
      study drug, 170 entered openlabel treatment, and 136 completed the study. 
      INTERVENTIONS: Patients receiving hydrocodone ER in the 12-week, 
      placebo-controlled study continued their previous dose unless adjustment was 
      needed; those previously receiving placebo (n=78) underwent dose 
      titration/adjustment to an analgesic dose (15-90 mg every 12 hours). Patients 
      received 22 weeks of open-label treatment. SAFETY: adverse events (AEs). 
      Maintenance of analgesia: worst pain intensity (WPI) and average pain intensity 
      (API) at each study visit. Aberrant drug behavior: study drug loss and diversion. 
      RESULTS: AEs were reported for 65/182 (36 percent) patients during dose 
      titration/ adjustment and 88/170 (52 percent) during open-label treatment. No 
      treatmentrelated serious AEs were reported. There were no clinically meaningful 
      trends in other safety assessments, including physical examinations and pure tone 
      audiometry. One patient receiving hydrocodone ER 30 mg twice daily experienced a 
      severe AE of neurosensory deafness that was considered treatment related. Mean 
      WPI and API remained steady throughout open-label treatment. Six (3 percent) 
      patients reported medication loss, and 5 (3 percent) reported diversion. 
      CONCLUSIONS: Abuse-deterrent hydrocodone ER was generally well tolerated in 
      patients with chronic low back pain, maintained efficacy, and was associated with 
      low rates of loss and diversion.
FAU - Hale, Martin E
AU  - Hale ME
AD  - Gold Coast Research, LLC, Plantation, Florida.
FAU - Ma, Yuju
AU  - Ma Y
AD  - Teva Pharmaceuticals, Frazer, Pennsylvania.
FAU - Malamut, Richard
AU  - Malamut R
AD  - Teva Pharmaceuticals, Frazer, Pennsylvania.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
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  - 6YKS4Y3WQ7 (Hydrocodone)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Analgesics, Opioid/*administration & dosage/adverse effects/chemistry
MH  - Chemistry, Pharmaceutical
MH  - Chronic Pain/diagnosis/*drug therapy
MH  - Delayed-Action Preparations
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Hydrocodone/*administration & dosage/adverse effects/chemistry
MH  - Low Back Pain/diagnosis/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Opioid-Related Disorders/*prevention & control/psychology
MH  - Pain Measurement
MH  - Prescription Drug Diversion/prevention & control
MH  - Prescription Drug Misuse/prevention & control
MH  - Risk Factors
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
EDAT- 2016/05/20 06:00
MHDA- 2016/09/14 06:00
CRDT- 2016/05/20 06:00
PHST- 2016/05/20 06:00 [entrez]
PHST- 2016/05/20 06:00 [pubmed]
PHST- 2016/09/14 06:00 [medline]
AID - jom.2016.0326 [pii]
AID - 10.5055/jom.2016.0326 [doi]
PST - ppublish
SO  - J Opioid Manag. 2016 May-Jun;12(2):139-47. doi: 10.5055/jom.2016.0326.