Pain and Chemical Dependency News

Fentanyl buccal tablet (FBT) for relief of breakthrough pain in opioid-treated patients with chronic low back pain: a randomized, placebo-controlled study

Short-acting opioids are commonly used to treat breakthrough pain and rapid-onset formulations are being developed to improve the effectiveness of this approach. Fentanyl buccal tablet (FBT) is a new formulation of fentanyl that enhances transbuccal drug delivery via an effervescent reaction and may provide relatively rapid-onset analgesia. FBT was evaluated for breakthrough pain in opioid-treated patients with chronic low back pain--the first such study in a population with chronic non-cancer pain.

This was a randomized, double-blind, placebo-controlled study. Patients with chronic low back pain received long-term opioid therapy at 16 pain treatment centers in the U.S. Following open-label titration to identify an effective dose, patients were randomly assigned to one of three double-blind dose sequences (six doses of FBT, three placebo) to treat nine breakthrough pain episodes. Pain intensity was measured on an 11-point scale (0 = no pain; 10 = worst pain), and other outcomes were assessed for 2 hours after dosing. The primary efficacy measure was the sum of pain intensity differences (PIDs) for the first 60 min; secondary efficacy measures included PIDs at other time points, pain relief, meaningful pain relief, time to meaningful pain relief, use of supplementary breakthrough pain medication, and self or investigator-reported adverse events.

Of the 124 patients screened, 105 patients were enrolled, 84 identified an effective FBT dose, and 77 entered the double-blind phase. Pain intensity differences for the first 60 min significantly favored FBT. All secondary measures also favored FBT, with PIDs and pain relief showing significant differences versus placebo as early as 10 and 15 min, respectively. An improvement in pain intensity score of > or = 33% occurred in a significantly larger proportion of FBT-treated episodes versus placebo from 15 min through 2 hours. Patients were approximately four times more likely to require supplemental opioids for BTP episodes following administration of placebo compared with episodes treated with FBT. Adverse effects were typical for opioids, and were mostly reported during dose titration. The study design may be a limitation of this reseach, and patients in pain clinics may not be representative of the general population with breakthrough pain. The researchers conclude that fentanyl buccal tablet was effective and well tolerated in the treatment of breakthrough pain in opioid-treated patients with chronic low back pain. Portenoy RK, Messina J, Xie F, Peppin J. Adapted from Curr Med Res Opin. 2007 Jan;23(1):223-33.

PMID: 17207304

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Credit: PubMed, developed by the National Center for Biotechnology Information (NCBI) at the National Library of Medicine (NLM).


Department of Pain Medicine and Palliative Care
©2005 Continuum Health Partners, Inc.