title: Efficacy, safety, and tolerability of fentanyl pectin nasal spray in patients with breakthrough cancer pain.
abstract: OBJECTIVE
  Assessment of analgesic effectiveness, safety, and tolerability of fentanyl pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain (BTcP) in routine clinical practice.
  
  
  METHODS
  A prospective, open-label, noninterventional study (4-week observation period, 3 month follow-up) of opioid-tolerant adults with BTcP in 41 pain and palliative care centers in Germany. Standardized BTcP questionnaires and patient diaries were used. Evaluation was made of patient-reported outcomes with respect to "time to first effect", "time to maximum effect", BTcP relief, as well as changes in BTcP-related impairment of daily life activities, quality-of-life restrictions, and health care resource utilization.
  
  
  RESULTS
  A total of 235 patients were recruited of whom 220 completed all questionnaires and reported on 1,569 BTcP episodes. Patients reported a significant reduction of maximum BTcP intensity (11-stage numerical rating scale [0= no pain, 10= worst pain conceivable]) with FPNS (mean ± standard deviation = 2.8±2.3) compared with either that reported at baseline (8.5±1.5), experienced immediately before FPNS application (7.4±1.7), or that achieved with previous BTcP medication (6.0±2.0; P<0.001 for each comparison). In 12.3% of BTcP episodes, onset of pain relief occurred ≤2 minutes and in 48.4% ≤5 minutes; maximum effects were reported within 10 minutes for 37.9% and within 15 minutes for 79.4%. By the end of the study, there had been significant improvements versus baseline in BTcP-related daily life activities (28.3±16.9 vs 53.1±11.9), physical (35.9±8.4 vs 26.8±6.5), and mental quality of life (38.7±8.5 vs 29.9±7.9) (P<0.001 for each comparison vs baseline); in addition, health care resource utilization requirements directly related to BTcP were reduced by 67.5%. FPNS was well tolerated; seven patients (3.2%) experienced eight treatment-emergent adverse events of which none was serious. There were no indicators of misuse or abuse.
  
  
  CONCLUSIONS
  FPNS provided rapid and highly effective BTcP relief in opioid-tolerant cancer patients with substantial improvements in daily functioning and quality of life. FPNS was well tolerated and associated with significant reductions in health care resource utilization and nursing assistance.
authors: Institute of Neurological Sciences, Nuremberg, Germany.
authors: Michael A
authors: MA
authors: Ueberall
authors: Institute of Nursing Science and Practice, Paracelsus Private Medical University of Salzburg, Salzburg, Austria.
authors: Stefan
authors: S
authors: Lorenzl
authors: Faculty of Medicine, Witten/Herdecke University, Witten, Germany; Clinic for Pain and Palliative Care Medicine, St.- Marien-Hospital, Luenen, Germany.
authors: Eberhard A
authors: EA
authors: Lux
authors: Department of Palliative Medicine, University Hospital Cologne, Cologne, Germany.
authors: Raymond
authors: R
authors: Voltz
authors: Archimedes Development Ltd., Nottingham, United Kingdom.
authors: Michael
authors: M
authors: Perelman
keywords: breakthrough pain; cancer; efficacy; fentanyl pectin nasal spray; intranasal administration; quality of life; safety