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.

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.

• Authors: Martin E Hale, Thomas R Zimmerman, Eli Eyal, Richard Malamut
• Journal: Journal of opioid management (J Opioid Manag) 2015 Nov-Dec Vol. 11 Issue 6 Pg. 507-18 ISSN: 1551-7489 [Print] United States
• PMID: 26728648 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics, Opioid
• Delayed-Action Preparations
• Tablets
• Hydrocodone

Topics

• Adult
• Aged
• Analgesics, Opioid (administration & dosage)
• Chronic Pain (drug therapy)
• Delayed-Action Preparations
• Double-Blind Method
• Female
• Humans
• Hydrocodone (administration & dosage, adverse effects)
• Low Back Pain (drug therapy)
• Male
• Middle Aged
• Opioid-Related Disorders (prevention & control)
• Tablets