• breakthrough pain;
  • cancer pain;
  • fentanyl buccal tablet;
  • opioid;
  • long-term therapy;
  • safety;
  • tolerability



This study assessed the long-term safety and tolerability of fentanyl buccal tablet (FBT) in opioid-tolerant patients with cancer and breakthrough pain (BTP) who were either naive to FBT or had completed 1 of 2 previous double-blind, placebo-controlled FBT studies (rollover patients).


Patients who were FBT-naive underwent titration to find a successful FBT dose. Rollover patients used a previously identified successful dose of FBT. Patients who achieved a successful dose were eligible to enter a maintenance phase (≥12 months). Safety assessments included adverse events (AEs), physical and neurologic examinations, and clinical laboratory tests.


Two hundred thirty-two patients were enrolled. A total of 112 entered titration; 79 identified a successful FBT dose, and 77 of these patients entered the maintenance phase along with 120 rollover patients (n = 197). AEs resulted in discontinuation of therapy for 33% of patients. The most common AEs were generally typical of opioids administered to cancer patients. All serious AEs were considered to be related to the patients' underlying conditions, except for 1 incident of FBT-related drug withdrawal syndrome. Sixty patients died after enrollment because of disease progression. Fifteen (6%) patients experienced ≥1 application-site AE, all of which were considered by investigators to be related to FBT.


FBT was generally well tolerated and had a favorable safety profile in the long-term (≥12 months) management of patients with persistent cancer pain and BTP. No unexpected AEs occurred. Safety and tolerability was similar to that observed in short-term studies. Cancer 2009. © 2009 American Cancer Society.