title: Fentanyl buccal tablet compared with immediate-release oxycodone for the management of breakthrough pain in opioid-tolerant patients with chronic cancer and noncancer pain: a randomized, double-blind, crossover study followed by a 12-week open-label phase to evaluate patient outcomes.
abstract: OBJECTIVE
  Evaluate analgesic efficacy, functional benefit, and patient satisfaction with fentanyl buccal tablet vs immediate-release oxycodone for breakthrough pain (BTP).
  
  
  METHODS
  Randomized, double-blind, active-controlled crossover trial and 12-week open-label extension.
  
  
  METHODS
  Forty-two U.S. sites.
  
  
  METHODS
  Opioid-tolerant patients with predominantly chronic noncancer pain experiencing BTP.
  
  
  METHODS
  Patients were randomized to open-label titration periods with fentanyl buccal tablet followed by oxycodone or vice versa for BTP management. After titrating to a successful dose of both medications (single dose providing adequate analgesia without unacceptable adverse events), patients were re-randomized to treat 10 BTP episodes with one medication and 10 with the other.
  
  
  METHODS
  The primary efficacy measure was pain intensity (PI) difference 15 minutes postdose. Secondary measures included PI difference 5, 10, 30, 45, and 60 minutes postdose; sum of PI differences 30 and 60 minutes postdose; ≥33% and ≥50% reduction in PI; and pain relief. Questionnaires assessed functional status/satisfaction.
  
  
  RESULTS
  Of 213 patients enrolled, 149 achieved a successful dose of both medications; 131 completed the double-blind phase and 112 the open-label phase. PI difference at 15 minutes (mean [standard deviation]) was greater with fentanyl buccal tablet (0.88 [1.20]) vs oxycodone (0.76 [1.13]; P < 0.001). Patients preferred fentanyl buccal tablet (47%) over oxycodone (35%); 18% had no preference. Patients and clinicians reported consistently better functional improvement and satisfaction with fentanyl buccal tablet vs short-acting opioids (P < 0.05).
  
  
  CONCLUSIONS
  Fentanyl buccal tablet was associated with rapid onset of analgesia and improvements in functional status and patient satisfaction compared with immediate-release oxycodone.
authors.affiliation: CRI Lifetree, Salt Lake City, Utah.
authors.forename: Lynn R
authors.initials: LR
authors.lastname: Webster
authors.forename: Kieran A
authors.initials: KA
authors.lastname: Slevin
authors.forename: Arvind
authors.initials: A
authors.lastname: Narayana
authors.forename: Craig Q
authors.initials: CQ
authors.lastname: Earl
authors.forename: Ronghua
authors.initials: R
authors.lastname: Yang
mesh_terms: D000278:Administration, Buccal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000008:administration & dosage*; D059390:Breakthrough Pain / Q000188:drug therapy* / Q000209:etiology; D059350:Chronic Pain / Q000188:drug therapy*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications; D010098:Oxycodone / Q000008:administration & dosage*; D059408:Pain Management / Q000379:methods*; D017060:Patient Satisfaction; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000700:Analgesics; D010098:Oxycodone; D005283:Fentanyl
keywords: Breakthrough Pain; Fentanyl Buccal Tablet; Opioid Tolerant; Oxycodone