Weinstein, S.M., Messina, J., & Xie, F. (2009). Fentanyl buccal tablet for the treatment of breakthrough pain in opioid-tolerant patients with chronic cancer pain: A long-term, open-label safety study. Cancer, 115(11), 2571–2579.doi: 10.1002/cncr.24279
To determine the long-term performance of fentanyl buccal tablet (FBT) in the treatment of breakthrough pain (BTP) in opioid-tolerant patients with chronic cancer pain; to assess the safety of FBT and how well patients tolerate it
In the screening phase, which lasted up to one week, patients underwent physical, laboratory, and neurologic examinations to determine whether they tolerated the test dose of FBT. In the titration phase, patients started with a therapy of 200 mcg FBT. Titration determined the effective dose. The study defined an effective dose as one that provided adequate relief from BTP within 30 minutes, without causing unacceptable adverse effects, for two episodes occurring at least four hours apart. Patients entered the 12-month maintenance phase when an effective dose of FBT was determined. In the maintenance phase, patients could take a second FBT.
Prospective repeated-measure, descriptive study
Patients tolerated FBT well for the study period, which lasted 12 months. The safety profile of FBT was favorable.
FBT is a favorable option for cancer patients with BTP and can be used safely over a long period.