Single-Dose And Steady-State Pharmacokinetics Of Moxduo™, A Dual-Opioid Formulation Containing A Fixed Ratio Of Morphine And Oxycodone

Authors: Webster L, Owen JS, Darling IM, Richards P, Kelen R, Stern W
Conference: American Pain Society (APS)
Keywords: accumulation index, central nervous, dose-normalized, female, general linear model, healthy, metabolites, neurology, noncompartmental, system agents, WinNonlin
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Introduction

  • Opioid analgesics are standard therapy for moderate to severe acute pain in many patients1
  • Q8003 (MoxDuo™) is the first dual-opioid combination product that has been evaluated in clinical trials. MoxDuo immediate-release capsules were developed for the management of acute moderate to severe pain and contain morphine sulfate and oxycodone hydrochloride combined in a fixed ratio of 3:2 by weight
  • The MoxDuo dosage forms currently being studied are 3/2 mg, 6/4 mg, 12/8 mg, and 18/12 mg
  • Use of opioids in combination has been shown to be an effective therapeutic strategy that results in lower drug consumption and fewer side effects than monotherapy.2-4 Moreover, MoxDuo may potentiate analgesia through interactions on a wider range of opioid subreceptors, including μ receptors (morphine) and κ receptors (oxycodone) 3-5
  • While the individual pharmacokinetic properties, including dose proportionality, of orally administered morphine and oxycodone are well documented,6,7 the pharmacokinetics of a therapeutic product combining these opioids has not been reported. The aim of the present study is to assess the dose proportionality of MoxDuo by examining the single-dose (3 mg/2 mg and 12 mg/8 mg morphine/oxycodone, respectively) and steady-state (12 mg/8 mg) pharmacokinetic properties of MoxDuo

American Pain Society (APS), Baltimore, Maryland, May 2010

By Lynn Webster, Md, Joel S. Owen, Phd, Rph, Inger Darling, Phd, Patricia Richards, Md, Phd, Robin Kelen, Rn, And Warren Stern, Phd