Fentanyl buccal soluble film (FBSF) for breakthrough pain in patients with cancer: a randomized, double-blind, placebo-controlled study.
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.


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.
Rauck
R
R
Carolinas Pain Institute, Winston-Salem, NC.
North
J
J
Carolinas Pain Institute, Winston-Salem, NC.
Gever
L N
LN
Meda Pharmaceuticals, Inc., Somerset, NJ, USA.
Tagarro
I
I
Meda Pharmaceuticals, Madrid, Spain.
Finn
A L
AL
BioDelivery Sciences International, Inc., Raleigh, NC, USA. Electronic address: afinn@bdsinternational.com.
D000278:Administration, Buccal; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects; D004304:Dosage Forms; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000188:drug therapy*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D010919:Placebos; D012995:Solubility; D016896:Treatment Outcome
D000701:Analgesics, Opioid; D004304:Dosage Forms; D010919:Placebos; D005283:Fentanyl