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Clinical outcomes during opioid titration following initiation with or conversion to Remoxy(R), an extended-release formulation of oxycodone.

Author(s): Roland CL, Setnik B, Cleveland JM, Brown DA

Affiliation(s): King Pharmaceuticals Research and Development, Inc., Pfizer Inc., Cary, NC 27513, USA. carl.roland@kingpharm.com

Publication date & source: 2011-07, Postgrad Med., 123(4):148-59.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Intra- and interpatient variability in opioid response usually necessitates opioid therapy titration to optimally balance analgesia and side effects, whether initiating therapy or converting from another opioid. Remoxy(R) (King Pharmaceuticals, Inc., Bristol, TN, which was acquired by Pfizer Inc in March 2011) is an extended-release formulation of oxycodone designed to maintain its rate-controlling mechanism following physical and chemical manipulation. A recent phase 3 trial, which required dose titration following initiation or conversion to Remoxy, demonstrated the long-term safety and efficacy of Remoxy in relieving moderate to severe chronic pain. In this study, opioid-naive patients were to be initiated on Remoxy 5 mg twice daily (10 mg total daily oxycodone dose) and opioid-experienced patients were to be converted to Remoxy at a dose equivalent to their previous opioid daily dose, determined from a conversion chart. A post-hoc analysis of study data provided clinically relevant information regarding initiation of or conversion to Remoxy. The intent-to-treat population (N=823) consisted of 429 opioid-experienced patients (52%) and 394 opioid-naive patients (48%). A stable Remoxy dose (defined as the first dose administered on 2 consecutive visits, whereby on the first of these visits, further dose titration was deemed unnecessary) was achieved by 325 opioid-experienced patients (76%; mean, 2.2 titration steps), of whom 278 (86%) successfully converted to Remoxy according to the prospectively determined post-hoc definition (</=4 titration steps). Of opioid-naive patients, 300 (76%) reached a stable dose of Remoxy (mean, 2.2 titration steps), 253 (84%) of whom successfully initiated on Remoxy. Pain intensity decreased from baseline to study completion by approximately 35% for both opioid-experienced and opioid-naive patients and adverse events were similar to those typically reported for opioids, with a higher incidence rate reported during titration (pre-stable dose period). These data provide important clinical information when initiating opioid-naive patients on or converting opioid-experienced patients to Remoxy.

Page last updated: 2011-12-09

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