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Fentanyl buccal tablet.

John Messina1, Mona Darwish, Perry G Fine

  • 1Cephalon, Inc., Frazer, Pennsylvania 19355, USA. jmessina@cephalon.com

Drugs of Today (Barcelona, Spain : 1998)
|February 28, 2008
PubMed
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Breakthrough pain (BTP) management is improved with fentanyl buccal tablets (FBT), offering rapid analgesia for cancer and non-cancer chronic pain patients. FBT provides faster relief than traditional opioids, with individually titrated doses for optimal outcomes.

Area of Science:

  • Pharmacology
  • Pain Management
  • Oncology

Background:

  • Breakthrough pain (BTP) is prevalent in chronic cancer and non-cancer pain conditions.
  • Traditional short-acting opioids have a delayed onset of analgesia, often not matching BTP's rapid intensity.
  • Fentanyl buccal tablet (FBT) utilizes OraVescent technology for rapid buccal absorption.

Purpose of the Study:

  • To evaluate the efficacy, safety, and tolerability of FBT for managing BTP in opioid-tolerant patients.
  • To compare FBT's rapid onset of analgesia against placebo in cancer and non-cancer pain populations.

Main Methods:

  • Open-label dose titration followed by randomized, placebo-controlled, double-blind studies.
  • Pain Intensity measured on an 11-point scale; primary outcome: Summed Pain Intensity Difference (SPID).

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  • Evaluated secondary outcomes including Pain Relief and proportion of episodes with significant pain reduction.

    • Main Results:

    • FBT significantly favored placebo for SPID at 30 minutes in cancer pain patients (p<0.0001).
    • FBT demonstrated significant improvements in pain relief and intensity reduction as early as 10-15 minutes in non-cancer pain patients.
    • Treatment with FBT was generally well-tolerated, with mild to moderate adverse events typical of opioid use.

    Conclusions:

    • FBT offers a rapid and effective treatment option for breakthrough pain in opioid-tolerant patients.
    • Individual dose titration of FBT is recommended for optimal effectiveness.
    • FBT shows promise in improving BTP management for both cancer and non-cancer chronic pain conditions.