Oral transmucosal fentanyl citrate for the treatment of breakthrough pain in cancer patients: An overview of its pharmacological and clinical characteristics

2005 ◽  
Vol 1 (1) ◽  
pp. 36 ◽  
Author(s):  
Kyriaki Mystakidou, MD, PhD ◽  
Emmanuela Katsouda, MD ◽  
Efi Parpa, BA, MA ◽  
Marinos L. Tsiatas, MD, PhD ◽  
Lambros Vlahos, MD, PhD
Keyword(s):  
Cancer Patients ◽  
Pain Treatment ◽  
Breakthrough Pain ◽  
Rapid Onset ◽  
Review Article ◽  
Brand Name ◽  
Fentanyl Citrate ◽  
Onset Of Action ◽  
Oral Transmucosal Fentanyl Citrate

Breakthrough pain is a transitory flare of pain occurring in most cancer patients against a background of otherwise controlled persistent pain. Treatment of breakthrough pain is a challenging phenomenon. Oral transmucosal fentanyl citrate (OTFC; brand name Actiqm, Cephalon Inc., West Chester, PA), a new opioid formulation with a unique delivery system, reflects the characteristics of breakthrough pain (rapid onset of action and short duration), making it an effective treatment for cancer patients who already receive opioids and experience flares of pain. This review article aims to present the role of oral transmucosal fentanyl citrate in the management of breakthrough pain in cancer patients. In particular, it is going to discuss the synthesis, clinical pharmacology, pharmacokinetic and pharmacodynamic properties, toxicity, and clinical efficacy of this novel agent.

Oral transmucosal fentanyl citrate (OTFC) for the treatment of breakthrough pain in cancer patients: a controlled dose titration study

Pain ◽  
1999 ◽  
Vol 79 (2) ◽  
pp. 303-312 ◽  
Author(s):  
Russell K Portenoy ◽  
Richard Payne ◽  
Paul Coluzzi ◽  
James W Raschko ◽  
Alan Lyss ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Breakthrough Pain ◽  
Dose Titration ◽  
Fentanyl Citrate ◽  
Oral Transmucosal Fentanyl Citrate ◽  
Titration Study

Dose-titration, multicenter study of oral transmucosal fentanyl citrate for the treatment of breakthrough pain in cancer patients using transdermal fentanyl for persistent pain.

1998 ◽  
Vol 16 (10) ◽  
pp. 3238-3245 ◽  
Author(s):  
J M Christie ◽  
M Simmonds ◽  
R Patt ◽  
P Coluzzi ◽  
M A Busch ◽  
...  
Keyword(s):  
Effective Dose ◽  
Cancer Patients ◽  
Breakthrough Pain ◽  
Persistent Pain ◽  
Baseline Data ◽  
Dose Titration ◽  
Transdermal Fentanyl ◽  
Fentanyl Citrate ◽  
Double Blind ◽  
Oral Transmucosal Fentanyl Citrate

PURPOSE Supplemental, "as-needed," administration of an opioid is a common approach to the problem of breakthrough pain in cancer patients. Oral transmucosal fentanyl citrate (OTFC) is undergoing investigation as a new treatment for breakthrough pain. The primary purpose of the study was to demonstrate that a single-unit dose of OTFC can safely and effectively treat breakthrough pain. A secondary goal was to determine appropriate dosing guidelines. PATIENTS AND METHODS This was a multicenter, randomized, double-blind, dose-titration study in 62 adult cancer patients using transdermal fentanyl for persistent pain. Consenting patients provided 2 days of baseline data to evaluate the performance of their usual breakthrough pain medication. Patients then randomly received 200 microg or 400 microg OTFC in double-blind fashion. (Patients were always assigned, rather than randomized, to 200 microg if 400 microg represented > 20% of around-the-clock medication.) Pain intensity (PI), pain relief (PR), and global satisfaction scores were recorded. OTFC was then titrated until the patient received adequate PR for each episode using one OTFC unit. Orders to titrate up were ignored one third of the time to improve the blind. Two days of baseline data were compared with 2 days of OTFC data after titration identified an effective dose of OTFC. RESULTS Most patients (76%) found a safe and effective dose of OTFC. There was no meaningful relationship between the around-the-clock opioid regimen and the effective dose of OTFC. In open-label comparisons, OTFC produced a faster onset of relief and a greater degree of PR than patients' usual breakthrough medication. Somnolence, nausea, and dizziness were the most common side effects associated with OTFC. CONCLUSION Most patients find a single OTFC dosage that adequately treats breakthrough pain. The optimal dose is found by titration and is not predicted by around-the-clock dose of opioids.

Fast-acting fentanyl for breakthrough pain

2018 ◽  
Author(s):  
Andrew N. Davies
Keyword(s):  
Randomized Controlled Trial ◽  
Breakthrough Pain ◽  
Controlled Trial ◽  
Rapid Onset ◽  
Fentanyl Citrate ◽  
Breakthrough Cancer Pain ◽  
Oral Transmucosal Fentanyl Citrate ◽  
Randomized Controlled ◽  
Double Blinded ◽  
Fast Acting

The landmark paper discussed in this chapter is ‘Oral transmucosal fentanyl citrate: Randomized, double-blinded, placebo-controlled trial for treatment of breakthrough pain in cancer patients’, published by Farrar et al. in 1998. It was the first description of a randomized controlled trial of a fast-acting fentanyl formulation for the management of breakthrough pain (i.e. oral transmucosal fentanyl citrate (OTFC)). Indeed, it was the first description of a randomized controlled trial of any of the so-called fast-acting fentanyl/rapid-onset opioid formulations for the management of breakthrough cancer pain. Moreover, the methodology employed in this study formed the basis for the methodology employed in many later studies (of other fast-acting fentanyl formulations).

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