title: Consistency of efficacy, patient acceptability, and nasal tolerability of fentanyl pectin nasal spray compared with immediate-release morphine sulfate in breakthrough cancer pain.
abstract: BACKGROUND
  We recently reported that fentanyl pectin nasal spray (FPNS) provides superior pain relief from breakthrough cancer pain (BTCP) compared with immediate-release morphine sulfate (IRMS), with significant effects by five minutes and clinically meaningful pain relief from 10 minutes postdose.
  
  
  OBJECTIVE
  To report the consistency of efficacy, tolerability, and patient acceptability of FPNS vs. IRMS.
  
  
  METHODS
  Patients (n=110) experiencing one to four BTCP episodes/day while taking ≥60 mg/day oral morphine (or equivalent) for background pain entered a double-blind, double-dummy (DB/DD), multiple-crossover study. Those who completed an open-label titration phase (n=84) continued to a DB/DD phase; 10 episodes were randomly treated with FPNS and overencapsulated placebo or IRMS and nasal spray placebo (five episodes each). Pain intensity (PI) and pain relief scores were assessed. Patient acceptability scores were assessed at 30 and 60 minutes. Safety and tolerability were assessed by adverse events (AEs) and nasal assessments.
  
  
  RESULTS
  Per-episode analysis revealed that FPNS consistently provided relief from pain more rapidly than IRMS; by 10 minutes, there were significant differences in PI difference scores and in the percentages of episodes showing clinically meaningful pain relief (P<0.05). Overall acceptability scores were significantly greater for FPNS than for IRMS at 30 (P<0.01) and 60 (P<0.05) minutes. Patients were "satisfied/very satisfied" with the convenience (79.8%) and ease of use (77.2%) of FPNS. Only 4.7% of patients withdrew from titration because of AEs; no significant nasal effects were reported.
  
  
  CONCLUSIONS
  This study demonstrates that FPNS is efficacious, well accepted, and well tolerated by patients with BTCP.
authors.affiliation: The Royal Marsden NHS Foundation Trust, Sutton, United Kingdom. andavies@doctors.org.uk
authors.forename: Andrew
authors.initials: A
authors.lastname: Davies
authors.forename: Thomas
authors.initials: T
authors.lastname: Sitte
authors.forename: Frank
authors.initials: F
authors.lastname: Elsner
authors.forename: Carlo
authors.initials: C
authors.lastname: Reale
authors.forename: Jose
authors.initials: J
authors.lastname: Espinosa
authors.forename: David
authors.initials: D
authors.lastname: Brooks
authors.forename: Marie
authors.initials: M
authors.lastname: Fallon
mesh_terms: D000281:Administration, Intranasal; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009369:Neoplasms / Q000150:complications*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010342:Patient Acceptance of Health Care; D017060:Patient Satisfaction; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D009020:Morphine; D005283:Fentanyl