Oral transmucosal fentanyl citrate in the management of breakthrough pain in cancer: an open, multicentre, dose-titration and long-term use study

2004 ◽  
Vol 18 (8) ◽  
pp. 698-704 ◽  
Author(s):  
G W Hanks ◽  
M Nugent ◽  
C M B Higgs ◽  
M A Busch
Keyword(s):  
Breakthrough Pain ◽  
Dose Titration ◽  
Fentanyl Citrate ◽  
Oral Transmucosal Fentanyl Citrate

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.

Long-term tolerability of fentanyl effervescent buccal tablets: Interim analysis in patients with cancer-related breakthrough pain

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8567-8567
Author(s):  
N. Slatkin ◽  
V. Charu ◽  
G. Niebler ◽  
R. Rauck
Keyword(s):  
Interim Analysis ◽  
Breakthrough Pain ◽  
Safety Data ◽  
Dose Titration ◽  
Open Label ◽  
Patients With Cancer ◽  
Titration Phase ◽  
Term Tolerability ◽  
Buccal Tablets

8567 Background: Fentanyl effervescent buccal tablets (FEBT) are designed to enhance the rate and efficiency of fentanyl absorption through the buccal mucosa. Results reported here represent a pre-specified interim analysis of an open-label safety and efficacy study of FEBT in opioid-tolerant patients with cancer-related breakthrough pain (BTP). Methods: Patients with cancer-related BTP receiving around-the-clock and supplemental opioids were eligible to enroll. Patients who had participated in a previous dose-titration study of FEBT enrolled directly into the 1-year phase; new patients entered a titration phase to determine an effective FEBT dose before entering the 1-year phase. An effective FEBT dose was defined as the dose needed to provide adequate analgesia for BTP. By October 3, 2005, 170 patients (aged 24 to 95 years) received FEBT (100–800 μg) and had documented safety data. Results: Of the 112 new patients, 70.5% identified an effective FEBT dose and were eligible for enrollment. In the long-term phase, patients received FEBT for a mean of 109.8 days; 8% at 100 μg, 15% at 200 μg, 23% at 400 μg, 25% at 600 μg, and 29% at 800 μg. The FEBT dose remained reasonably stable during the long-term phase, but 43 patients had a dose increase and 6 had a dose decrease at the discretion of the investigator. Only 2 patients required a change in the FEBT dose because of tolerability. The most common adverse events (AEs) are given in the table. The incidence of AEs did not correlate with the effective FEBT dose. The 42 patient deaths that occurred were all attributed to cancer-related pathology or the progression of cancer. Conclusions: Overall, FEBT was well tolerated in opioid-tolerant patients with cancer-related BTP. [Table: see text] [Table: see text]

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.

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