title: Fentanyl sublingual spray for breakthrough cancer pain in patients receiving transdermal fentanyl.
abstract: OBJECTIVE
  To investigate the relationship between effective fentanyl sublingual spray (FSS) doses for breakthrough cancer pain (BTCP) and around-the-clock (ATC) transdermal fentanyl patch (TFP).
  
  
  METHODS
  Adults tolerating ATC opioids received open-label FSS for 26 days, followed by a 26-day double-blind phase for patients achieving an effective dose (100-1600 µg).
  
  
  RESULTS
  Out of 50 patients on ATC TFP at baseline, 32 (64%) achieved an effective dose. FSS effective dose moderately correlated with mean TFP dose (r = 0.4; p = 0.03). Patient satisfaction increased during the study. Common adverse event included nausea (9%) and peripheral edema (9%).
  
  
  CONCLUSIONS
  FSS can be safely titrated to an effective dose for BTCP in patients receiving ATC TFP as chronic cancer pain medication. ClinicalTrials.gov identifier: NCT00538850.
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ 85719, USA.
authors.forename: David S
authors.initials: DS
authors.lastname: Alberts
authors.affiliation: INSYS Therapeutics, Chandler, AZ 85286, USA.
authors.forename: Christina Cognata
authors.initials: CC
authors.lastname: Smith
authors.affiliation: INSYS Therapeutics, Chandler, AZ 85286, USA.
authors.forename: Neha
authors.initials: N
authors.lastname: Parikh
authors.affiliation: Carolinas Pain Institute, & The Center for Clinical Research, Winston-Salem, NC 27103, USA.
authors.forename: Richard L
authors.initials: RL
authors.lastname: Rauck
mesh_terms: D000279:Administration, Cutaneous; D000286:Administration, Sublingual; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D059390:Breakthrough Pain / Q000188:drug therapy*; D000072716:Cancer Pain / Q000188:drug therapy*; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D005283:Fentanyl
keywords: breakthrough cancer pain; fentanyl sublingual spray; transmucosal immediate-release fentanyl