PMID- 21334555
OWN - NLM
STAT- MEDLINE
DCOM- 20110705
LR  - 20131121
IS  - 1873-6513 (Electronic)
IS  - 0885-3924 (Linking)
VI  - 41
IP  - 2
DP  - 2011 Feb
TI  - Consistency of efficacy, patient acceptability, and nasal tolerability of 
      fentanyl pectin nasal spray compared with immediate-release morphine sulfate in 
      breakthrough cancer pain.
PG  - 358-66
LID - 10.1016/j.jpainsymman.2010.11.004 [doi]
AB  - CONTEXT: 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. 
      OBJECTIVES: 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. CONCLUSION: This study demonstrates that FPNS is efficacious, well 
      accepted, and well tolerated by patients with BTCP.
CI  - Copyright (c) 2011 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. 
      All rights reserved.
FAU - Davies, Andrew
AU  - Davies A
AD  - The Royal Marsden NHS Foundation Trust, Sutton, United Kingdom. 
      andavies@doctors.org.uk
FAU - Sitte, Thomas
AU  - Sitte T
FAU - Elsner, Frank
AU  - Elsner F
FAU - Reale, Carlo
AU  - Reale C
FAU - Espinosa, Jose
AU  - Espinosa J
FAU - Brooks, David
AU  - Brooks D
FAU - Fallon, Marie
AU  - Fallon M
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Pain Symptom Manage
JT  - Journal of pain and symptom management
JID - 8605836
RN  - 0 (Analgesics, Opioid)
RN  - 76I7G6D29C (Morphine)
RN  - UF599785JZ (Fentanyl)
SB  - IM
MH  - Administration, Intranasal
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Analgesics, Opioid/administration & dosage/adverse effects/*therapeutic use
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Female
MH  - Fentanyl/administration & dosage/adverse effects/*therapeutic use
MH  - Humans
MH  - Intention to Treat Analysis
MH  - Male
MH  - Middle Aged
MH  - Morphine/administration & dosage/adverse effects/*therapeutic use
MH  - Neoplasms/*complications
MH  - Pain/*drug therapy/etiology
MH  - Patient Acceptance of Health Care
MH  - Patient Satisfaction
MH  - Treatment Outcome
EDAT- 2011/02/22 06:00
MHDA- 2011/07/06 06:00
CRDT- 2011/02/22 06:00
PHST- 2010/07/01 00:00 [received]
PHST- 2010/11/24 00:00 [revised]
PHST- 2010/11/24 00:00 [accepted]
PHST- 2011/02/22 06:00 [entrez]
PHST- 2011/02/22 06:00 [pubmed]
PHST- 2011/07/06 06:00 [medline]
AID - S0885-3924(10)01026-2 [pii]
AID - 10.1016/j.jpainsymman.2010.11.004 [doi]
PST - ppublish
SO  - J Pain Symptom Manage. 2011 Feb;41(2):358-66. doi: 
      10.1016/j.jpainsymman.2010.11.004.