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Fentanyl buccal tablet for the treatment of breakthrough pain in opioid-tolerant patients with chronic cancer pain†

A long-term, open-label safety study

  1. Sharon M. Weinstein MD1,‡,*,
  2. John Messina PharmD2,
  3. Fang Xie PhD2

Article first published online: 16 APR 2009

DOI: 10.1002/cncr.24279

Issue

Cancer

Cancer

Volume 115, Issue 11, pages 2571–2579, 1 June 2009

Additional Information

How to Cite

Weinstein, S. M., Messina, J. and Xie, F. (2009), Fentanyl buccal tablet for the treatment of breakthrough pain in opioid-tolerant patients with chronic cancer pain. Cancer, 115: 2571–2579. doi: 10.1002/cncr.24279

Author Information

  1. 1

    Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah

  2. 2

    Cephalon, Inc, Frazer, Pennsylvania

  1. ‡

    Fax: (801) 585-0159

*Huntsman Cancer Institute, University of Utah, 2000 Circle of Hope, Room 2151, Salt Lake City, UT 84112

  1. †

    The authors thank the investigators: Jacob Abraham, MD; Andrea Baxter, MD; Patrick Beatty, MD; Ali Ben-Jacob, MD; Donald Berdeaux, MD; Debra Brandt, MD; Donald Brooks, MD; Daniel Buffington, MD; Jennifer Caskey, MD; Veena Charu, MD; Michael Drass, MD; David Ellison, MD; Orlando Florete, MD; Nashat Gabrail, MD; Gregory Guzley, MD; Martin E. Hale, MD; Youssef Hanna, MD; Mohamed Haq, MD; Jeffrey Hines, MD; Timothy Houden, MD; Haresh Jhangiani, MD; Edward Kaplan, MD; Ronald Kawauchi, MD; Christine Laramee, MD; Gary Lee, MD; Luis A. Meza, MD; Johnny Nacilla, MD; Srinivas Nalamachu, MD; Ravi Patel, MD; John Peppin, DO; Dat Pham, MD; J. Talisman Pomeroy, MD; Russell Portenoy, MD; Richard Rauck, MD; Prabhakara Reddy, MD; Evangeline Reyes, MD; John Roberts, MD; Marc Saltzman, MD; Thalia Segal, MD; Neal Slatkin, MD; Scott Sonnier, MD; Raymond Sorensen, MD; Forrest Swan, MD; Donald Taylor, MD; Howard Terebelo, MD; Rajbala Thakur, MD; John Thropay, MD; James Weick, MD; and Michael Wertheim, MD.

Publication History

  1. Issue published online: 20 MAY 2009
  2. Article first published online: 16 APR 2009
  3. Manuscript Accepted: 17 NOV 2008
  4. Manuscript Revised: 14 NOV 2008
  5. Manuscript Received: 21 AUG 2008

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Keywords:

  • breakthrough pain;
  • cancer pain;
  • fentanyl buccal tablet;
  • opioid;
  • long-term therapy;
  • safety;
  • tolerability

This study followed an opioid-tolerant patient population with chronic cancer pain for ≥12 months to evaluate a medication indicated for the treatment of breakthrough pain. The results demonstrated that fentanyl buccal tablets were generally well tolerated and had a favorable safety profile.

Abstract

BACKGROUND:

This study assessed the long-term safety and tolerability of fentanyl buccal tablet (FBT) in opioid-tolerant patients with cancer and breakthrough pain (BTP) who were either naive to FBT or had completed 1 of 2 previous double-blind, placebo-controlled FBT studies (rollover patients).

METHODS:

Patients who were FBT-naive underwent titration to find a successful FBT dose. Rollover patients used a previously identified successful dose of FBT. Patients who achieved a successful dose were eligible to enter a maintenance phase (≥12 months). Safety assessments included adverse events (AEs), physical and neurologic examinations, and clinical laboratory tests.

RESULTS:

Two hundred thirty-two patients were enrolled. A total of 112 entered titration; 79 identified a successful FBT dose, and 77 of these patients entered the maintenance phase along with 120 rollover patients (n = 197). AEs resulted in discontinuation of therapy for 33% of patients. The most common AEs were generally typical of opioids administered to cancer patients. All serious AEs were considered to be related to the patients' underlying conditions, except for 1 incident of FBT-related drug withdrawal syndrome. Sixty patients died after enrollment because of disease progression. Fifteen (6%) patients experienced ≥1 application-site AE, all of which were considered by investigators to be related to FBT.

CONCLUSIONS:

FBT was generally well tolerated and had a favorable safety profile in the long-term (≥12 months) management of patients with persistent cancer pain and BTP. No unexpected AEs occurred. Safety and tolerability was similar to that observed in short-term studies. Cancer 2009. © 2009 American Cancer Society.

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