title: A randomized, placebo-controlled study of fentanyl buccal tablet for breakthrough pain in opioid-treated patients with cancer.
abstract: OBJECTIVE
  Cancer-related breakthrough pain (BTP) is typically managed with a short-acting oral opioid, taken as needed during a fixed-schedule opioid regimen. The conventional approach may not provide the onset of analgesia required for BTP for many patients, because the onset of analgesia with short-acting opioids lags behind the time course of the majority of episodes of BTP. The fentanyl buccal tablet (FBT) employs a novel delivery system that enhances the rate and extent of absorption of fentanyl through the buccal mucosa. This double-blind, randomized, placebo-controlled study evaluated the efficacy, safety, and tolerability of FBT in opioid-treated patients with cancer-related BTP.
  
  
  METHODS
  After an open-label titration (N=123) to identify an effective FBT dose to treat BTP episodes, 77 patients were randomly assigned to 1 of 18 prespecified dose sequences of 10 tablets (7 FBT and 3 placebo). Pain intensity, pain relief (PR), and global performance of the medication were recorded at regular time intervals between 15 and 60 minutes. Pain intensity differences (PID), the summed PID (SPID), and summed total PR were calculated. The SPID at 30 minutes (SPID30) was the primary efficacy variable. Adverse events were reported.
  
  
  RESULTS
  Sixty-five percent (80/123) of patients were titrated to an effective dose. The mean (SE) SPID30 for FBT was 3.0+/-0.12 versus 1.8+/-0.18 for placebo (P<0.0001). Measures of PR, PID, SPID, summed total PR, and patient ratings of global performance of medication significantly favored FBT over placebo at all time points. Adverse events were typical of opioid drugs. Poor oral tolerability was noted in 2 patients.
  
  
  CONCLUSIONS
  FBT is efficacious and safe in the treatment of cancer-related BTP.
authors.affiliation: Beth Israel Medical Center, New York, NY 10003, USA. rportenoy@chpnet.org
authors.forename: Russell K
authors.initials: RK
authors.lastname: Portenoy
authors.forename: Donald
authors.initials: D
authors.lastname: Taylor
authors.forename: John
authors.initials: J
authors.lastname: Messina
authors.forename: Lothar
authors.initials: L
authors.lastname: Tremmel
mesh_terms: D000278:Administration, Buccal; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy; D010146:Pain / Q000175:diagnosis / Q000209:etiology* / Q000517:prevention & control*; D010147:Pain Measurement / Q000187:drug effects; D015990:Placebo Effect; D013607:Tablets; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D004338:Drug Combinations; D013607:Tablets; D005283:Fentanyl