Analgesic and adverse effects of a fixed-ratio morphine-oxycodone combination
(MoxDuo) in the treatment of postoperative pain.
Author(s): Richards P, Riff D, Kelen R, Stern W; MoxDuo Study Team.
Collaborators: Diamond E, Gottlieb I, Raymond G, Riff D, Seegmiller D, Tallis A.
Affiliation(s): QRxPharma, Inc., Clinical Research, Bedminster, New Jersey, USA.
Publication date & source: 2011, J Opioid Manag. , 7(3):217-28
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 > or = 2 on the 4-point Likert scale and > or = 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). MoxDuo6 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 morphine-equivalent 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.
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