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January 17, 2012 Formulary Drug Listing Decisions OXYCODONE/NALOXONE CONTROLLED RELEASE Indication (s) Drug Profile Products available in Canada: TARGIN™ (oxycodone/naloxone controlled release) Manufacturer: Purdue Pharma n There are no long-term trials (beyond 12 weeks) investigating the efficacy The relief of moderate to severe pain in of oxycodone/naloxone CR in chronic adults who require continuous, aroundpain. the-clock opioid analgesia for several days or more. The naloxone component is n Oxycodone/naloxone CR has been associated with improvements in indicated for the relief of opioid-induced constipation outcomes compared to constipation (OIC). OxyContin®. However, outcomes such as patient well-being or quality of life DAC Recommendation have not been investigated. The Drug Advisory Committee (DAC) n The efficacy of oxycodone/naloxone CR recommended that oxycodone/naloxone has not been compared adequately to controlled release (CR) NOT be listed on OxyContin® plus a preventative bowel any WSIB formulary as there are no trials regimen. providing evidence that it demonstrates an advantage to comparators currently n Oxycodone/naloxone CR is associated listed on the WSIB formularies. with adverse effects consistent with opioid therapy. The WSIB Decision n Although naloxone may theoretically Based on the DAC’s recommendation, the WSIB has decided NOT to list oxycodone/ naloxone CR on any of the WSIB formularies at this time. Formulary Status Oxycodone/naloxone CR IS NOT listed on any WSIB formularies at this time. Recommendation Highlights n Oxycodone/naloxone CR is a combi- nation product containing the opioid analgesic oxycodone and is currently approved for the treatment of moderate to severe pain in adults who require continuous, around-the-clock opioid analgesia for several days or more. Naloxone is an opioid antagonist that has been added to alleviate oxycodoneinduced constipation. lower the risk of opioid abuse, studies pertaining to the abuse potential of oxycodone/ naloxone CR have not been published. n No cost-effectiveness studies were located. n The DAC concluded that an indepen- dent review of the clinical efficacy, safety, and cost-effectiveness of oxycodone/naloxone CR did not indicate any therapeutic or non-therapeutic advantage in the treatment of chronic noncancer pain over appropriate comparators available on WSIB formularies. Consequently, the DAC recommended that oxycodone/ naloxone CR NOT be listed on any WSIB formulary. n Oxycodone/naloxone CR appears to provide similar (but not superior) analgesic efficacy to OxyContin®. Page 1 of 2 DETAILED DISCUSSION Background Oxycodone/naloxone controlled release (CR) is a long-acting combination opioid product marketed as Targin™ in Canada. Oxycodone is a mu opioid receptor agonist that provides analgesic relief. Naloxone is an opioid receptor antagonist, added to counteract oxycodone-induced constipation. Naloxone has limited oral systemic bioavailability; its effect is limited to the gastrointestinal tract and, as such, it will not induce opioid withdrawal when taken orally. However, non-oral routes of administration can induce withdrawal effects. Summary of Committee Considerations The DAC considered an external, independent review of the clinical efficacy, safety, and cost-effectiveness of oxycodone/naloxone CR in the treatment of chronic non-cancer pain (CNCP). The review included published and unpublished randomized controlled trials (RCTs) that were at least single-blind. Three RCTs comparing oxycodone/naloxone CR to OxyContin® or placebo were included in the review. The studies enrolled subjects reporting moderate to severe pain secondary to musculoskeletal (mainly lower back pain or osteoarthritis) or neurological conditions. All trials were of 12 weeks duration. Bowel function was the primary outcome investigated in two trials, while occurrence of pain events was the primary outcome in the third trial. No significant differences between oxycodone/naloxone CR and OxyContin® were reported in any of the trials in mean daily oxycodone doses, measures of pain, or the need for rescue medications. Inadequate reporting of treatment estimates, lack of non-inferiority design, and the short duration of the trials were notable limitations in demonstrating equivalent analgesic efficacy between oxycodone/naloxone CR and OxyContin®. Oxycodone/naloxone CR was associated with better bowel function compared to OxyContin® (e.g., lower constipation-related effects, higher frequency of bowel movements, and lower use of laxatives). The clinical relevance of these effects with respect to patient wellbeing and quality of life were not assessed. It is uncertain if subjects taking OxyContin® concurrently used an adequate preventative bowel regimen. As such, the clinical benefit of oxycodone/naloxone CR versus Oxycontin® and an adequate preventative bowel regimen has not been established (guidelines generally recommend preventative bowel regimens be prescribed with opioids). The most commonly reported adverse effects for oxycodone/naloxone CR across all trials were gastrointestinal (constipation, diarrhea, nausea, and vomiting). The abuse potential of oxycodone/naloxone CR has not been investigated in any published trials. Although the naloxone component of the product may confer a potentially lower risk of abuse and addiction compared to other opioids, studies demonstrating such an advantage are lacking. No cost-effectiveness studies were identified. The Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-cancer Pain recommends a stepped approach when initiating opioids in individuals who have been thoroughly assessed and screened. The Ontario Drug Benefit Program does not list oxycodone/naloxone CR as a general benefit. The drug is currently under consideration by the Common Drug Review. Based on the available evidence, the DAC concluded that there was no compelling evidence demonstrating a therapeutic or non-therapeutic advantage for oxycodone/ naloxone CR over opioid comparators (plus a preventative bowel regimen) in the treatment of CNCP. Furthermore, several alternative drug classes and laxatives are available on the WSIB formularies that can meet the treatment needs of the majority of injured/ill workers. Hence the DAC recommended that oxycodone/naloxone CR not be listed on any WSIB formularies. Revised: January 29, 2013 The WSIB will consider all relevant facts and circumstances, and shall make its decision based upon the merits and justice of a particular case. Page 2 of 2