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

Rauck R, North J, Gever LN, Tagarro I, Finn AL - Ann. Oncol. (2009)

Bottom Line: 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.In this study, FBSF was well tolerated in the oral cavity, with no reports of treatment-related oral AEs.

View Article: PubMed Central - PubMed

Affiliation: Carolinas Pain Institute, Winston-Salem, NC, USA.

ABSTRACT

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.

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Related in: MedlinePlus

Overall satisfaction with study drug.
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fig4: Overall satisfaction with study drug.

Mentions: The percentage of episodes with a 33% or 50% decrease in pain was also significantly greater with FBSF than with placebo (Table 2). Overall satisfaction with the study drug was significantly greater with FBSF than with placebo (mean score 2.0 versus 1.5, respectively; P < 0.001). Moreover, more patients rated their overall satisfaction with FBSF as good, very good, or excellent compared with placebo (Figure 4). Conversely, fewer patients rated their overall satisfaction with FBSF as poor or fair compared with placebo (Figure 4). The mean (± SEM) number of episodes when rescue medication was used was significantly lower after treatment with FBSF than with placebo (30.0% ± 3.5% versus 44.6% ± 4.4%; P = 0.002).


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

Rauck R, North J, Gever LN, Tagarro I, Finn AL - Ann. Oncol. (2009)

Overall satisfaction with study drug.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2875549&req=5

fig4: Overall satisfaction with study drug.
Mentions: The percentage of episodes with a 33% or 50% decrease in pain was also significantly greater with FBSF than with placebo (Table 2). Overall satisfaction with the study drug was significantly greater with FBSF than with placebo (mean score 2.0 versus 1.5, respectively; P < 0.001). Moreover, more patients rated their overall satisfaction with FBSF as good, very good, or excellent compared with placebo (Figure 4). Conversely, fewer patients rated their overall satisfaction with FBSF as poor or fair compared with placebo (Figure 4). The mean (± SEM) number of episodes when rescue medication was used was significantly lower after treatment with FBSF than with placebo (30.0% ± 3.5% versus 44.6% ± 4.4%; P = 0.002).

Bottom Line: 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.In this study, FBSF was well tolerated in the oral cavity, with no reports of treatment-related oral AEs.

View Article: PubMed Central - PubMed

Affiliation: Carolinas Pain Institute, Winston-Salem, NC, USA.

ABSTRACT

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.

Show MeSH
Related in: MedlinePlus