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.

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.

• The sample was composed of 232 patients in the safety population and 197 patients in the maintenance population.
• Mean patient age was 55.3 years (SD = 12.7 years).
• Of all patients, 122 (53%) were female and 110 (47%) were male.
• The sample consisted of opioid-tolerant patients with cancer and BTP in several categories: 107 patients (46%) had nociceptive pain, 42 patients (18%) had neuropathic pain, and 83 patients (36%) had mixed pain.

• Multisite
• Outpatient
• Forty-seven centers in the United States

Prospective repeated-measure, descriptive study

• Data about adverse events observed by investigators or reported by patients, to measure safety
• Daily diary, to record number of BTP episodes and number of FBTs taken 
• Daily global medication performance assessment scale (0 = poor, 4 = excellent)
• Seven-item scale, which patients were to complete before and one month after starting treatment, to assess medication (Only 25% completed the latter assessment.)

• Of all patients, 42% remained in the maintenance phase for 12 months.
• Clinicians were able to identify a successful FBT dose for 71% of all patients.
• Of all patients, 33% discontinued treatment as the result of adverse events typical of opioids (nausea was the most common). As the result of disease progression, 60 patients died after enrollment in the study.
• Patients tolerated FBT well, and the medication had a favorable safety profile.

Patients tolerated FBT well for the study period, which lasted 12 months. The safety profile of FBT was favorable.

• The study had a risk of bias due to no appropriate control group.
• Not all patients completed all measures.

FBT is a favorable option for cancer patients with BTP and can be used safely over a long period.