Abstract
Oral transmucosal delivery of fentanyl is a rapid and proven route of administration for the management of breakthrough pain in cancer patients.1,2 The BEMA drug delivery system was designed to improve oral transmucosal dosing reliability, tolerability and patient acceptance. This bilayer polymer delivery system can control the mucosal surface application area and time in contact with the mucosa, optimizing delivery and pharmacokinetics of buccally delivered fentanyl. The linearity of plasma fentanyl concentrations across a range of doses and the absolute bioavailability of fentanyl were explored in two Phase 1 pharmacokinetic studies.
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