PMID- 21424794
OWN - NLM
STAT- MEDLINE
DCOM- 20120608
LR  - 20211020
IS  - 1433-7339 (Electronic)
IS  - 0941-4355 (Linking)
VI  - 20
IP  - 3
DP  - 2012 Mar
TI  - Long-term tolerability, efficacy and acceptability of fentanyl pectin nasal spray 
      for breakthrough cancer pain.
PG  - 565-73
LID - 10.1007/s00520-011-1124-x [doi]
AB  - PURPOSE: Previous studies show that fentanyl pectin nasal spray (FPNS) rapidly 
      provides clinically meaningful pain relief in the treatment of breakthrough 
      cancer pain (BTCP). This study assessed the long-term tolerability, acceptability 
      and consistency of effect of FPNS in patients with BTCP. METHODS: Patients (new 
      and rolled over from earlier controlled studies) with cancer experiencing one to 
      four episodes per day of BTCP whilst taking >/= 60 mg/day of morphine (or 
      equivalent) given orally for cancer pain entered an open-label 16-week safety 
      study. Safety and tolerability were assessed by adverse events (AEs), adverse 
      drug reactions (ADRs), withdrawal due to AEs and by nasal assessments. 
      Acceptability assessments included ratings of overall satisfaction with each 
      treated episode and ease of use and convenience of FPNS. Additional rescue 
      medication and dose stability were used to evaluate the consistency of effect. 
      RESULTS: Four hundred three patients were included in the safety and 
      intent-to-treat analysis (42,227 episodes), 356 entered the treatment phase and 
      110 completed 16 weeks. Overall, 24.6% of 403 patients reported treatment-related 
      treatment-emergent AEs that were generally mild/moderate and typical of opioids; 
      20 patients discontinued treatment due to an AE (9 were ADRs). Nasal assessments 
      revealed no clinically significant effects; 94% of FPNS-treated episodes required 
      no additional rescue medication. More than 90% of patients did not have to 
      increase their dose during the study. Patients reported overall satisfaction with 
      FPNS for 90.1% of episodes. At week 12, 96.9% of patients were satisfied with the 
      ease of use and 97.9% with the convenience of FPNS. CONCLUSIONS: FPNS was 
      generally well tolerated and well accepted for the treatment of BTCP, and doses 
      remained stable over the 4-month study period.
FAU - Radbruch, Lukas
AU  - Radbruch L
AD  - Klinik fur Palliativmedizin, Universitatsklinikum Bonn, Sigmund-Freud-Str. 25, 
      53127 Bonn, Germany. Lradbruch@Ukaachen.de
FAU - Torres, Luis M
AU  - Torres LM
FAU - Ellershaw, John E
AU  - Ellershaw JE
FAU - Gatti, Antonio
AU  - Gatti A
FAU - Luis Lerzo, Guillermo
AU  - Luis Lerzo G
FAU - Revnic, Julia
AU  - Revnic J
FAU - Taylor, Donald
AU  - Taylor D
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20110322
PL  - Germany
TA  - Support Care Cancer
JT  - Supportive care in cancer : official journal of the Multinational Association of 
      Supportive Care in Cancer
JID - 9302957
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Nasal Sprays)
RN  - 76I7G6D29C (Morphine)
RN  - 89NA02M4RX (Pectins)
RN  - UF599785JZ (Fentanyl)
SB  - IM
MH  - Absorption
MH  - Administration, Intranasal
MH  - Administration, Oral
MH  - Analgesics, Opioid/administration & dosage/pharmacokinetics
MH  - Breakthrough Pain/*drug therapy/etiology
MH  - Female
MH  - Fentanyl/*administration & dosage/pharmacokinetics
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Morphine/administration & dosage
MH  - Nasal Mucosa/metabolism
MH  - Nasal Sprays
MH  - Neoplasms/*complications
MH  - Pain Measurement
MH  - *Patient Satisfaction
MH  - Pectins/administration & dosage/pharmacokinetics
EDAT- 2011/03/23 06:00
MHDA- 2012/06/09 06:00
CRDT- 2011/03/23 06:00
PHST- 2010/07/08 00:00 [received]
PHST- 2011/02/20 00:00 [accepted]
PHST- 2011/03/23 06:00 [entrez]
PHST- 2011/03/23 06:00 [pubmed]
PHST- 2012/06/09 06:00 [medline]
AID - 10.1007/s00520-011-1124-x [doi]
PST - ppublish
SO  - Support Care Cancer. 2012 Mar;20(3):565-73. doi: 10.1007/s00520-011-1124-x. Epub 
      2011 Mar 22.