title: Clinical outcomes during opioid titration following initiation with or conversion to Remoxy®, an extended-release formulation of oxycodone.
abstract: 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® (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-naïve 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-naïve 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-naïve 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-naïve 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-naïve patients on or converting opioid-experienced patients to Remoxy.
authors.affiliation: King Pharmaceuticals Research and Development, Inc., Pfizer Inc., Cary, NC 27513, USA. carl.roland@kingpharm.com
authors.forename: Carl L
authors.initials: CL
authors.lastname: Roland
authors.forename: Beatrice
authors.initials: B
authors.lastname: Setnik
authors.forename: Jody M
authors.initials: JM
authors.lastname: Cleveland
authors.forename: David A
authors.initials: DA
authors.lastname: Brown
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010098:Oxycodone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D010146:Pain / Q000188:drug therapy*; D013810:Therapeutic Equivalency; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D010098:Oxycodone