Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects
Status:
Completed
Trial end date:
2007-04-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the efficacy of BEMA Fentanyl (Onsolis) at any dose
in the management of breakthrough pain in cancer subjects on background opioid therapy. The
standard of care for these breakthrough pain episodes is a rapid onset, short acting
analgesic with minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are
routinely used, but because of slow and variable oral absorption, the pain control is not the
best with these products. Oral transmucosal fentanyl citrate (OTFC) has been used
successfully in treating breakthrough pain episodes associated with cancer. OTFC is a lozenge
of fentanyl on a stick and is administered by continuously swabbing the interior of the
subject's mouth until the product is dissolved (approximately 15 to 30 minutes). The buccal
route of administration avoids the delay and variability associated with oral absorption.