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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

Mean sum of pain intensity difference (SPID) scores over time.*P < 0.05; **P < 0.01; ***P < 0.001. SEM, standard error of the mean.
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fig2: Mean sum of pain intensity difference (SPID) scores over time.*P < 0.05; **P < 0.01; ***P < 0.001. SEM, standard error of the mean.

Mentions: The LSM ± SEM of the SPID30, the primary efficacy variable, 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). The SPID values for FBSF-treated episodes were consistently greater compared with placebo-treated episodes at all postdose time points. There was statistically significant separation from placebo starting at 15 min postdose (P < 0.05) through 60 min postdose [the last time point assessed (P < 0.001)] (Figure 2).


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)

Mean sum of pain intensity difference (SPID) scores over time.*P < 0.05; **P < 0.01; ***P < 0.001. SEM, standard error of the mean.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

fig2: Mean sum of pain intensity difference (SPID) scores over time.*P < 0.05; **P < 0.01; ***P < 0.001. SEM, standard error of the mean.
Mentions: The LSM ± SEM of the SPID30, the primary efficacy variable, 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). The SPID values for FBSF-treated episodes were consistently greater compared with placebo-treated episodes at all postdose time points. There was statistically significant separation from placebo starting at 15 min postdose (P < 0.05) through 60 min postdose [the last time point assessed (P < 0.001)] (Figure 2).

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