title: Long-term safety of fentanyl sublingual spray in opioid-tolerant patients with breakthrough cancer pain.
abstract: The current study assessed the long-term safety of fentanyl sublingual spray for managing breakthrough cancer pain (BTCP).
  
  
  
  This open-label, multicenter study enrolled both de novo and rollover patients who completed a double-blind, efficacy trial. Eligible patients were ≥18 years of age and experiencing pain that was being managed with an around-the-clock opioid yet were experiencing ≤4 BTCP episodes daily and were opioid-tolerant (i.e., receiving ≥60 mg/day oral morphine or an equivalent dose of another opioid for ≥1 week). De novo patients initially entered a 21-day titration period to identify an effective dose of fentanyl sublingual spray (100-1600 μg), then entered a 90-day maintenance period. The incidence of adverse events (AEs), results of laboratory tests, vital sign assessments, and treatment satisfaction were assessed.
  
  
  
  Of the 269 patients (de novo, 179; rollover, 90) who entered the maintenance period, 163 (60.6 %) completed the study; the primary reason for discontinuation was an AE (22.3 %). Eighty percent of patients identified an effective dose of fentanyl sublingual spray (median dose, 600 μg). The most common AEs differed from the titration period (nausea (13 %), vomiting (12 %), and somnolence (10 %)) to the maintenance period (malignant neoplasm progression (24 %), vomiting (16 %), and peripheral edema (12 %)). Few changes in laboratory parameters and vital sign assessments were observed. Patients generally reported being more satisfied with fentanyl sublingual spray than with their previous BTCP treatment.
  
  
  
  This long-term maintenance study demonstrated that fentanyl sublingual spray was generally safe and well tolerated for managing BTCP over a 90-day period.
authors.affiliation: Department of Anesthesiology, Memorial Herman Memorial City Medical Center, 921 Gessner Road, Houston, TX, 77024, USA. Harold@Minkowitzmd.com.
authors.forename: Harold
authors.initials: H
authors.lastname: Minkowitz
authors.affiliation: Four Seasons Hospice and Palliative Care, Flat Rock, NC, USA.
authors.forename: Janet
authors.initials: J
authors.lastname: Bull
authors.affiliation: Better Health Clinical Research, Newnan, GA, USA.
authors.forename: R Charles
authors.initials: RC
authors.lastname: Brownlow
authors.affiliation: Clinical Operations, INSYS Therapeutics, Inc., Chandler, AZ, USA.
authors.forename: Neha
authors.initials: N
authors.lastname: Parikh
authors.affiliation: Medical Department, Carolinas Pain Institute and The Center for Clinical Research, Winston Salem, NC, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Rauck
mesh_terms: D000286:Administration, Sublingual; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects*; D059390:Breakthrough Pain / Q000188:drug therapy*; D000072716:Cancer Pain / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage / Q000009:adverse effects*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D000701:Analgesics, Opioid; D005283:Fentanyl
keywords: Breakthrough pain; Cancer pain; Fentanyl sublingual spray; Opioids