Breakthrough Pain (BTP) in Opioid-Tolerant Cancer Patients: A Pan-European Open-Label Multicentre Study with Fentanyl Buccal Tablet (FBT)

ABSTRACT BTP, a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain, is a common problem in cancer patients. FBT is indicated for the treatment of BTP in adults with cancer already receiving maintenance opioid therapy for chronic cancer pain and should be titrated to an effective dose that provides adequate analgesia and minimises undesirable events. In this study, patients entered a screening period and were randomized during an open-label titration period to a starting FBT dose of 100 µg (group A) or 200 µg (group B) to identify the FBT effective dose and then treated in an open-label period (for 8 BTP episodes). Patients' inclusion followed…