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Canadian Drug Review Reimbursement Decision

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  Nucynta CR
Generic tapentadol
Company Janssen Inc.
Indication pain
Condition Nervous system
Submission Type
Patient Population Tapentadol has a Health Canada indication for the management of moderate to moderately severe pain in adults who require continuous treatment for several days or more. Tapentadol is a centrally acting synthetic opioid analgesic thought to act as a mu-opioid agonist and through the inhibition of norepinephrine reuptake. It is available as 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg CR tablets. The Health Canada-recommended dose of tapentadol CR is 100 mg to 250 mg twice daily, taken approximately every 12 hours; opioid-naive patients should initiate treatment with 50 mg twice daily, and then be individually titrated to an optimal dose within the recommended range.
Status Complete
Date of Recommendation 2011-09-28
Recommendation Summary Do not list
Recommendation Details The Canadian Expert Drug Advisory Committee (CEDAC) recommends that tapentadol controlled release (CR) not be listed.
Reason for Recommendation The Committee considered the data from three active-controlled double blind randomized controlled trials (RCTs) to be insufficient to determine the relative efficacy of tapentadol CR compared with oxycodone CR, due to the high and unbalanced frequency of patient withdrawals (tapentadol CR range, 44% to 48%; oxycodone CR range, 60% to 65%), much of which occurred during the initial three-week titration phase. Of Note: There are no RCTs comparing tapentadol CR with less costly long-acting opioid formulations of codeine, morphine, or hydromorphone.
Clinical Report:
Pharmacoeconomic Report:
Final Recommendation Report: CDR clinical report  CADTH-CDR Final Recommendation report

†The information referenced on this page is compiled from publicly available documents published by CADTH and is available through the embedded links.

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