Fentanyl buccal tablet for the treatment of breakthrough pain in opioid-tolerant patients with chronic cancer pain: A long-term, open-label safety study.
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 (>or=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 >or=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 (>or=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.
Weinstein
Sharon M
SM
Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah 84112, USA. sharon.weinstein@hci.utah.edu
Messina
John
J
Xie
Fang
F
D000278:Administration, Buccal; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D002908:Chronic Disease; D018450:Disease Progression; D004361:Drug Tolerance; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage* / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D013997:Time Factors
D000701:Analgesics, Opioid; D005283:Fentanyl