Fentanyl buccal tablet for the treatment of breakthrough pain in opioid‐tolerant patients with chronic cancer pain

Abstract

BACKGROUND: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Fentanyl Buccal Tablets for Breakthrough Pain in Highly Tolerant Cancer Patients: Preliminary Data on the Proportionality Between Breakthrough Pain Dose and Background Dose

“…Similarly, in a recent long-term study of FBT, the mean dose of FBTwas 554 mg in patients who were receiving mean doses of 240 mg/day oral morphine equivalents as background analgesia, and approximately half of the patients used the maximum FBT dose of 800 mg during maintenance treatment. 12 These mean doses of FBT (554 mg) were consistently higher than those eventually calculated with a proportional approach (400 mg for mean doses of 240 mg of oral morphine equivalents as around-the-clock analgesia), confirming that overdosing with proportional doses calculated according to the opioid basal regimen is unlikely. These patients, however, needed titration, with evident suffering during the days before achieving the right dose.…”

“…This is the first study assessing the use of high doses of FBT for BTcP, as data on doses higher than 800 mg of FBT have never been published. 11,12 In all previous experiences with FBT, patients who did not obtain satisfactory analgesia with 800 mg discontinued the study. 13 A pharmacokinetic study has shown that higher doses of FBT produce a proportional increase in plasma concentration.…”

Long-term efficacy and tolerability of intranasal fentanyl in the treatment of breakthrough cancer pain

“…Fentanyl buccal tablet (FBT) was well tolerated and had a favorable safety profile in a long-term (up to 12 months) management of BTP. Adverse effects were unrelated to study drug [40]. Subsequently, FBT has been assessed for 12 weeks in an open-label extension phase after completing a controlled study with oral opioids in both cancer and non-cancer patients.…”

Transmucosal Immediate-Release Fentanyl for Breakthrough Cancer Pain: Opportunities and Challenges for Use in Palliative Care

“…[64][65][66] In a double-blind, randomized, placebo-controlled study, 123 patients were titrated to an efficacious dose, with 77 patients randomly assigned to 1 of 18 prespecified dose sequences of 10 tablets (7 fentanyl buccal tablets and 3 placebo). Pain intensity, pain relief, and global performance were measured at fixed dose intervals between 15 and 60 minutes.…”