Fentanyl Transdermal Matrix Patch (Durotep?? MT Patch; Durogesic?? DTrans??; Durogesic?? SMAT)

Abstract

The fentanyl transdermal matrix patch is approved in Japan for the management of moderate to severe cancer-related pain in adults. Bioequivalence, in terms of exposure and the maximum and minimum serum concentrations, has been established between the fentanyl transdermal matrix patch 16.8 mg (100microg/h) and the fentanyl transdermal reservoir patch 10 mg (100microg/h) after single and multiple applications. The fentanyl transdermal matrix patch 2.1-8.4 mg (12.5-50microg/h) effectively managed chronic cancer-related pain in adults in a noncomparative, multicentre, phase II study; 89.4% of recipients rated their global assessment of pain as 'very satisfied', 'satisfied' or 'neither satisfied nor dissatisfied'. Adults with cancer- or non-cancer-related chronic pain were switched from fentanyl transdermal reservoir patch to fentanyl transdermal matrix patch therapy without compromising efficacy; no differences in pain intensity or sleep interference scores were seen between the two formulations in an nonblind, multicentre, switching pilot study. Given the nature of the therapy, the tolerability profile of the fentanyl transdermal matrix patch was generally acceptable. Topical adverse events included erythema, application-site irritation and pruritus. In general, patients and physicians preferred the fentanyl transdermal matrix patch over the fentanyl transdermal reservoir patch in the pilot study.