PMID- 21046929
OWN - NLM
STAT- MEDLINE
DCOM- 20101116
LR  - 20191111
IS  - 1551-7489 (Print)
IS  - 1551-7489 (Linking)
VI  - 6
IP  - 5
DP  - 2010 Sep-Oct
TI  - Long-term safety, tolerability, and consistency of effect of fentanyl pectin 
      nasal spray for breakthrough cancer pain in opioid-tolerant patients.
PG  - 319-28
AB  - OBJECTIVE: to assess the long-term safety, tolerability, and consistency of 
      effect of fentanyl pectin nasal spray (FPNS) in patients with breakthrough cancer 
      pain (BTCP). DESIGN: a multicenter, open-label study. PATIENTS: patients with 
      chronic cancer pain treated with > or = 60 mg/d oral morphine or equivalent 
      experiencing 1-4 episodes per day of BTCP. INTERVENTION: all patients entered 
      into a 16-week treatment phase after undergoing a dose-titration phase with FPNS. 
      MAIN OUTCOME MEASURES: safety and tolerability were assessed by adverse events 
      (AEs) and by nasal tolerability assessments. Consistency of effect was monitored 
      through additional rescue medication use and FPNS dose change. RESULTS: four 
      hundred three patients were included in the safety analyses. Of these, 356 
      patients entered the treatment phase and 110 patients completed the study. FPNS 
      was self-administered for 42,227 episodes. During the treatment phase, 99 
      patients (24.6 percent) reported treatment-related AEs; most were mild or 
      moderate and typical of opioids. Serious AEs were reported by 61 patients (15.1 
      percent), but only five were considered related to study drug. Of the 80 deaths 
      that occurred during this study, one was assessed as possibly related to study 
      drug. Nasal assessments revealed no significant local effects. No additional 
      rescue medication was required after 94 percent of FPNS-treated episodes. More 
      than 90 percent of patients required no increase in their initial dose of FPNS. 
      CONCLUSIONS: FPNS use for BTCP was associated with AEs, typical of opioids, with 
      no evidence of nasal toxicity. A large proportion of BTCP episodes were treated 
      with a single dose, and doses remained stable over the 4-month period.
FAU - Portenoy, Russell K
AU  - Portenoy RK
AD  - Department of Pain Medicine and Palliative Care, Beth Israel Medical Center, New 
      York, New York, USA.
FAU - Raffaeli, William
AU  - Raffaeli W
FAU - Torres, Luis M
AU  - Torres LM
FAU - Sitte, Thomas
AU  - Sitte T
FAU - Deka, Akhil Chandra
AU  - Deka AC
FAU - Herrera, Ileana Gonzalez
AU  - Herrera IG
FAU - Wallace, Mark S
AU  - Wallace MS
CN  - Fentanyl Nasal Spray Study 045 Investigators Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Opioid Manag
JT  - Journal of opioid management
JID - 101234523
RN  - 0 (Analgesics, Opioid)
RN  - 89NA02M4RX (Pectins)
RN  - UF599785JZ (Fentanyl)
SB  - IM
EIN - J Opioid Manag. 2010 Nov-Dec;6(6):407
EIN - J Opioid Manag. 2011 Jan-Feb;7(1):26
MH  - Administration, Intranasal
MH  - Adult
MH  - Aged
MH  - Analgesics, Opioid/*administration & dosage
MH  - Chronic Disease
MH  - Drug Tolerance
MH  - Female
MH  - Fentanyl/*administration & dosage/adverse effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/*physiopathology
MH  - Pain, Intractable/*drug therapy
MH  - Pectins/*administration & dosage
MH  - Prospective Studies
EDAT- 2010/11/05 06:00
MHDA- 2010/11/17 06:00
CRDT- 2010/11/05 06:00
PHST- 2010/11/05 06:00 [entrez]
PHST- 2010/11/05 06:00 [pubmed]
PHST- 2010/11/17 06:00 [medline]
AID - 10.5055/jom.2010.0029 [doi]
PST - ppublish
SO  - J Opioid Manag. 2010 Sep-Oct;6(5):319-28. doi: 10.5055/jom.2010.0029.