Analgesic and adverse effects of a fixed-ratio morphine-oxycodone combination (MoxDuo®) in the treatment of postoperative pain

Patricia Richards, MD, PhD; Dennis Riff, MD; Robin Kelen, RN; Warren Stern, PhD

doi:10.5055/jom.2011.0064

Authors

Patricia Richards, MD, PhD
Dennis Riff, MD
Robin Kelen, RN
Warren Stern, PhD

DOI:

https://doi.org/10.5055/jom.2011.0064

Keywords:

pain, dual opioid, opioid, MoxDuo, morphine, oxycodone, bunionectomy, analgesia, morphine-equivalent dose, adverse events, nausea, emesis, dizziness

Abstract

Objective: To compare efficacy and safety profiles of an immediate-release morphine and oxycodone Dual-Opioid® combination (MoxDuo®) versus its individual components and versus its morphine-equivalent doses in moderate to severe postoperative pain patients.
Design: Randomized, double-blind, 48-hour, parallel-treatment, multicenter, six-arm study of MoxDuo.
Setting: Six US centers.
Patients: Within 6 hours after bunionectomy surgery, patients were eligible if they reported pain intensity 2 on the 4-point Likert scale and 4 on an 11-point Numerical Pain Rating Scale (197 randomly assigned; 175 completers).
Interventions: MoxDuo 12 mg/8 mg, MoxDuo 6 mg/4 mg, morphine 12 mg, oxycodone 8 mg, morphine 6 mg, or oxycodone 4 mg (all administered q6h).
Main outcome measure: Sum of pain intensity differences 0-24 hours after the first dose of study medication (SPID24) and percentage of patients with moderate to severe nausea, emesis, or dizziness.
Results: SPID24 was significantly better in the MoxDuo 12 mg/8 mg group when compared with its individual components (morphine 12 mg [p = 0.009] and oxycodone 8 mg [p = 0.037]), and when compared with MoxDuo 6 mg/4 mg (p = 0.011; 54.3 vs 28.5, 35.7, and 30.0, respectively). MoxDuo 6 mg/4 mg and its morphine-equivalent doses (morphine 12 mg and oxycodone 8 mg) had comparable analgesic effects. There was a 50-75 percent reduction in moderate to severe adverse events (AEs) commonly associated with opioids (ie, nausea, vomiting, and dizziness) in the MoxDuo 6 mg/4 mg group when compared with its morphineequivalent dose groups.
Conclusions: MoxDuo produced superior analgesic effects when compared with its individual components, but comparable efficacy when compared with its morphine-equivalent doses. Common AEs were reduced at least 50 percent with MoxDuo when compared with its morphine-equivalent doses. MoxDuo may be an improved intervention in the management of moderate to severe acute pain.

Author Biographies

Patricia Richards, MD, PhD

QRxPharma, Inc., Clinical Research, Bedminster, New Jersey.

Dennis Riff, MD

Advanced Clinical Research Institute, Anaheim, California.

Robin Kelen, RN

QRxPharma, Inc., Clinical Research, Bedminster, New Jersey.

Warren Stern, PhD

QRxPharma, Inc., Clinical Development, Bedminster, New Jersey

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