Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy
Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the safety of BEMA fentanyl 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.
BioDelivery Sciences International, Inc. (BDSI) has developed BEMA (BioErodible MucoAdhesive)
fentanyl, an alternative product to OTFC that does not require the subject to continuously
paint the inside of the mouth with the dosage form. The BDSI product is a small disc that is
placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the disc
readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of
the disc are water soluble, so the entire dosage form dissolves within 30 minutes of
application.