A randomized, double-blind, placebo-controlled study of the efficacy and safety of MNK-795, a dual-layer, biphasic, immediate-release and extended-release combination analgesic for acute pain.

Abstract

OBJECTIVE:

To investigate the efficacy and safety of a bilayer combination oxycodone (OC) and acetaminophen (APAP) analgesic with both immediate-release and extended-release (ER) components (OC/APAP ER) in patients with moderate to severe pain using an established acute pain model.

RESEARCH DESIGN AND METHODS:

This was a randomized, double-blind, placebo-controlled trial. Adult patients were included in the study if they had a pain intensity score≥4 on a 0-10 numerical rating scale after bunionectomy surgery, and were randomized (1:1) to receive four doses (two tablets q12h) of OC/APAP ER or placebo.

CLINICAL TRIAL REGISTRATION:

NCT01484652.

MAIN OUTCOME MEASURES:

The primary efficacy endpoint was the summed pain intensity difference over the first 48 hours (SPID48). Secondary endpoints included SPIDs and total pain relief (TOTPAR) over the dosing intervals; time to perceptible, meaningful, and confirmed pain relief; and the proportion of patients with ≥30% reduction in pain intensity scores.

RESULTS:

A total of 329 patients were enrolled, of whom 266 (OC/APAP ER, n=135; placebo, n=131) completed the study. The mean (SE) SPID48 was 114.9 (7.6) in the OC/APAP ER group and 66.9 (7.6) in the placebo group (P<0.0001). SPID and TOTPAR values were significantly greater with OC/APAP ER than with placebo over all time periods analyzed, and the median times to perceptible, meaningful, and confirmed pain relief were significantly shorter. More patients showed ≥30% reduction in pain intensity scores with OC/APAP ER than with placebo at all times after 0.5 hours. OC/APAP ER was generally well tolerated. A limitation of this study was the lack of an active comparator.

CONCLUSIONS:

OC/APAP ER was efficacious and generally well tolerated in an established model of moderate to severe acute pain, providing an onset of analgesia in approximately 30 minutes and sustained pain relief over the 12 hour dosing period.

• Authors: Neil Singla, Thomas Barrett, Lisa Sisk, Kenneth Kostenbader, Jim Young, Michael Giuliani
• Journal: Current medical research and opinion (Curr Med Res Opin) Vol. 30 Issue 3 Pg. 349-59 (Mar 2014) ISSN: 1473-4877 [Electronic] England
• PMID: 24351079 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics
• Delayed-Action Preparations
• Drug Combinations
• Placebos
• oxycodone-acetaminophen
• Acetaminophen
• Oxycodone

Topics

• Acetaminophen (administration & dosage, adverse effects, therapeutic use)
• Acute Pain (drug therapy)
• Adult
• Analgesics (adverse effects, therapeutic use)
• Delayed-Action Preparations
• Double-Blind Method
• Drug Combinations
• Female
• Humans
• Male
• Middle Aged
• Oxycodone (administration & dosage, adverse effects, therapeutic use)
• Placebos