PMID- 19940014
OWN - NLM
STAT- MEDLINE
DCOM- 20100927
LR  - 20211020
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Print)
IS  - 0923-7534 (Linking)
VI  - 21
IP  - 6
DP  - 2010 Jun
TI  - Fentanyl buccal soluble film (FBSF) for breakthrough pain in patients with 
      cancer: a randomized, double-blind, placebo-controlled study.
PG  - 1308-1314
LID - S0923-7534(19)39305-6 [pii]
LID - 10.1093/annonc/mdp541 [doi]
AB  - BACKGROUND: Fentanyl buccal soluble film (FBSF) has been developed as a treatment 
      of breakthrough pain in opioid-tolerant patients with cancer. The objective of 
      this study was to evaluate the efficacy of FBSF at doses of 200-1200 microg in 
      the management of breakthrough pain in patients with cancer receiving ongoing 
      opioid therapy. PATIENTS AND METHODS: This was a multicenter, randomized, 
      double-blind, placebo-controlled, multiple-crossover study that included 
      opioid-tolerant adult patients with chronic cancer pain who experienced one to 
      four daily episodes of breakthrough pain. The primary efficacy assessment was the 
      sum of pain intensity differences at 30 min (SPID30) postdose. RESULTS: The 
      intent-to-treat population consisted of 80 patients with > or =1 post-baseline 
      efficacy assessment. The least-squares mean (LSM +/- SEM) of the SPID30 was 
      significantly greater for FBSF-treated episodes of breakthrough pain than for 
      placebo-treated episodes (47.9 +/- 3.9 versus 38.1 +/- 4.3; P = 0.004). There was 
      statistical separation from placebo starting at 15 min up through 60 min (last 
      time point assessed). There were no unexpected adverse events (AEs) or clinically 
      significant safety findings. CONCLUSIONS: FBSF is an effective option for control 
      of breakthrough pain in patients receiving ongoing opioid therapy. In this study, 
      FBSF was well tolerated in the oral cavity, with no reports of treatment-related 
      oral AEs.
FAU - Rauck, R
AU  - Rauck R
AD  - Carolinas Pain Institute, Winston-Salem, NC.
FAU - North, J
AU  - North J
AD  - Carolinas Pain Institute, Winston-Salem, NC.
FAU - Gever, L N
AU  - Gever LN
AD  - Meda Pharmaceuticals, Inc., Somerset, NJ, USA.
FAU - Tagarro, I
AU  - Tagarro I
AD  - Meda Pharmaceuticals, Madrid, Spain.
FAU - Finn, A L
AU  - Finn AL
AD  - BioDelivery Sciences International, Inc., Raleigh, NC, USA. Electronic address: 
      afinn@bdsinternational.com.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20091125
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Dosage Forms)
RN  - 0 (Placebos)
RN  - UF599785JZ (Fentanyl)
SB  - IM
MH  - Administration, Buccal
MH  - Adult
MH  - Aged
MH  - Analgesics, Opioid/administration & dosage/adverse effects
MH  - Dosage Forms
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Fentanyl/*administration & dosage/adverse effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/complications/*drug therapy
MH  - Pain/*drug therapy/etiology
MH  - Pain Measurement
MH  - Placebos
MH  - Solubility
MH  - Treatment Outcome
PMC - PMC2875549
EDAT- 2009/11/27 06:00
MHDA- 2010/09/29 06:00
PMCR- 2009/11/25
CRDT- 2009/11/27 06:00
PHST- 2009/11/27 06:00 [entrez]
PHST- 2009/11/27 06:00 [pubmed]
PHST- 2010/09/29 06:00 [medline]
PHST- 2009/11/25 00:00 [pmc-release]
AID - S0923-7534(19)39305-6 [pii]
AID - 10.1093/annonc/mdp541 [doi]
PST - ppublish
SO  - Ann Oncol. 2010 Jun;21(6):1308-1314. doi: 10.1093/annonc/mdp541. Epub 2009 Nov 
      25.