Pain Clinical Trial
Official title:
An Open Label, Long-term Treatment Evaluation of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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