Efficacy, safety and pharmacokinetic study of a novel fentanyl-containing matrix transdermal patch system in Japanese patients with cancer pain.

Clinical Drug Investigation
Toyo MiyazakiShigeto Mashimo

Abstract

A novel transdermal matrix patch delivery system for fentanyl has been developed to deliver improved management of cancer pain compared with that obtained using current fentanyl reservoir patches. This study was carried out to assess the efficacy, safety and pharmacokinetic profiles of a 12.5 microg/h transdermal matrix fentanyl patch administered with the objective of replacing morphine, oral oxycodone or fentanyl injection formulations. The study also evaluated how the pharmacokinetic profiles of higher dose fentanyl patches (25, 37.5 and 50 microg/h) changed following dose adjustments to optimize management of cancer pain. This open-label, multicentre study involved 87 patients of both sexes (> or =20 years) with a confirmed diagnosis of cancer. Patients were receiving any one of the following at the time of enrollment for the management of their cancer pain: (a) morphine <45 mg/day orally, <30 mg/day as suppositories, or <15 mg/day by injection; (b) oral oxycodone <30 mg/day; or (c) fentanyl injectable preparations <0.3 mg/day. The patients were administered a 3-day course of fentanyl transdermal matrix patch application three times. The initial dose was 12.5 microg/h, which could be increased when a new patch was applied i...Continue Reading

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Citations

Feb 20, 2013·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Majella E Lane
Oct 31, 2009·Targeted Oncology·Francesco AtzoriBruno Massidda
May 20, 2017·Clinical Journal of Oncology Nursing·Jeannine M BrantLinda H Eaton
Feb 22, 2014·International Journal of Biological Macromolecules·Gunjan SarkarDipankar Chattopadhyay

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