title: A report on the long-term use of fentanyl pectin nasal spray in patients with recurrent breakthrough pain.
abstract: BACKGROUND
  As patients with cancer are living longer, there is a need to ensure that treatments used for palliative care are well tolerated and effective during long-term use.
  
  
  OBJECTIVE
  To investigate the long-term use of fentanyl pectin nasal spray (FPNS) for the treatment of breakthrough pain in cancer (BTPc) in patients receiving regular opioid therapy.
  
  
  METHODS
  Adult patients (N = 401) taking at least 60 mg/day oral morphine or equivalent, experiencing one to four episodes of BTPc a day, entered an open-label long-term study (NCT00458510). Patients had either completed an FPNS randomized controlled trial or were newly identified. Of these, 171 patients continued into an extension study. Up to four episodes of BTPc a day were treated with FPNS at 100-800 μg titrated doses. During the extension study, patients visited the clinic every four weeks for assessment and reporting of adverse events (AEs).
  
  
  RESULTS
  There were 163 patients with documented FPNS use. The mean duration of use was 325 days; 46 patients used FPNS for ≥360 days; the maximum duration was 44 months. Seventy percent of patients did not change their FPNS dose; 2% of patients withdrew from the study because of the lack of efficacy. The most common AEs, aside from disease progression, were insomnia, 9.9%; nausea, 9.4%; vomiting, 9.4%; and peripheral edema, 9.4%. The overall incidence of FPNS-related AEs was 11.1%, the most common being constipation (4.1%), with no apparent dose relationship. Ten patients (5.8%) experienced nasal AEs, most of which were mild or moderate.
  
  
  CONCLUSIONS
  FPNS appeared to provide sustained benefit and was well tolerated during long-term treatment of BTPc.
authors.affiliation: Georgia Center for Cancer Pain Management & Palliative Medicine, Marietta, Georgia, USA. Electronic address: dtaylor@cpcnopain.com.
authors.forename: Donald
authors.initials: D
authors.lastname: Taylor
authors.affiliation: Klinik für Palliativmedizin, Universitätsklinikum Bonn, Bonn, Germany.
authors.forename: Lukas
authors.initials: L
authors.lastname: Radbruch
authors.affiliation: Hôpital Jean Jaurès, Paris, France.
authors.forename: Julia
authors.initials: J
authors.lastname: Revnic
authors.affiliation: Hospital Universitario Puerta del Mar, Cádiz, Spain.
authors.forename: Luis M
authors.initials: LM
authors.lastname: Torres
authors.affiliation: Marie Curie Palliative Care Institute, Liverpool, United Kingdom.
authors.forename: John E
authors.initials: JE
authors.lastname: Ellershaw
authors.affiliation: Archimedes Development Ltd., Nottingham, United Kingdom.
authors.forename: Michael
authors.initials: M
authors.lastname: Perelman
mesh_terms: D000281:Administration, Intranasal / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D059390:Breakthrough Pain / Q000188:drug therapy* / Q000503:physiopathology; D004338:Drug Combinations; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000627:therapeutic use; D059085:Nasal Sprays; D009369:Neoplasms / Q000503:physiopathology; D010166:Palliative Care; D010368:Pectins / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D004338:Drug Combinations; D059085:Nasal Sprays; D009020:Morphine; D010368:Pectins; D005283:Fentanyl
keywords: Breakthrough; FPNS; cancer; fentanyl; long-term; pain; palliative care