A Randomized, Double-Blind, Placebo-Controlled Study of Fentanyl Buccal Tablets for Breakthrough Pain: Efficacy and Safety in Japanese Cancer Patients

Kosugi, Toshifumi; Hamada, Sasagu; Takigawa, Chizuko; Shinozaki, Kazuo; Kunikane, Hiroshi; Goto, Fumio; Tanda, Shigeru; Shima, Yasuo; Yomiya, Kinomi; Matoba, Motohiro; Adachi, Isamu; Yoshimoto, Tetsusuke; Eguchi, Katsumi

doi:10.1016/j.jpainsymman.2013.07.006

Cited by 21 publications

(7 citation statements)

References 22 publications

(11 reference statements)

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“…PID was significantly better for the buccal fentanyl product than for placebo from 30 min onwards, but no significant difference was noted at earlier assessments at 15 min. 70 …”

Section: Clinical Efficacymentioning

confidence: 99%

Rapid acting fentanyl formulations in breakthrough pain in cancer. Drug selection by means of the System of Objectified Judgement Analysis

et al. 2017

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Drug selection of rapid acting fentanyl formulations in the treatment of breakthrough pain in patients with cancer is performed by the System of Objectified Judgement Analysis method. All seven available formulations were included in the analysis. The following selection criteria were used: number of available strengths, variability in the rate of absorption, interactions, clinical efficacy, side effects, ease of administration and documentation. No direct double-blind comparative studies between two or more formulations were identified and the clinical documentation of all formulations is limited. The most distinguishing criterion was ease of use. This led to slightly higher scores for Abstral, Instanyl and PecFent than for the other formulations. The pros and cons of each formulation should be discussed with the patient, and the most suitable formulation selected for each individual patient.

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“…PID was significantly better for the buccal fentanyl product than for placebo from 30 min onwards, but no significant difference was noted at earlier assessments at 15 min. 70 …”

Section: Clinical Efficacymentioning

confidence: 99%

Rapid acting fentanyl formulations in breakthrough pain in cancer. Drug selection by means of the System of Objectified Judgement Analysis

et al. 2017

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“…Studies reported heterogenous outcomes, with a tendency towards improved outcomes with FBT in different pain assessment instruments. 21,23,[25][26][27][28] Two studies compared FBT with oral morphine or oxycodone, with FBT showing significantly superior. 21,23 In a multicenter, placebo controlled, double blind study with 83 cancer patients, Portenoy et al compared fentanyl pectin nasal spray (FPNS) with placebo using Sum of Pain Intensity Difference (SPID), Pain Relief (PR), and Volume 14, Nomor 1, Tahun 2022 Pain Intensity Difference (PID) as outcome measure.…”

Section: Resultsmentioning

confidence: 99%

Breakthrough Cancer Pain: The Current Pharmacological Management

Mochamat

Nugroho

Wicaksono

2022

JAI b

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Background: Breakthrough pain (BTP) is a transient increase in pain that occurs on a background of stable pain. It contributes substantially to the suffering experienced by most cancer patients. The pharmacologic options for management of BTP have been expanded considerably in the past decade. Opioids remain the most effective pharmaceuticals used for the BTP case. In this systematic review we attempted to provide the currently available clinical data about pharmacological treatment for breakthrough cancer pain.Objective: To evaluate the efficacy of pharmacological treatments for Breakthrough painMethods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) and PubMed for the last ten years (from September 2010 to September 2020. Further potentially relevant studies were identified from reference lists of studies marked for inclusion and relevant reviews. Two review authors independently assessed trial quality and extracted data. We screened the search results and included studies if they met the selection criteria.Result: We screened 205 publications of which 14 met the inclusion criteria. In total, we analysed data from 2129 participants. Overall, participant with BTP were treated with short acting opioid. Literature searching did not find any published evidence of non opioid drug to treat the BTP. Most adverse effects of the investigated drugs seemed to be moderate.Conclusion: The findings of this review suggest that rapid onset opioids play significant role for BTP. Future studies may be conducted to explore the efficacy and safety profiles each regimen for patients with certain categories of cancer.

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“…This was an open-label, noncomparative study aimed to assess the efficacy and safety of FBSF dosage in proportional to the background opioid regimen. Dose proportional to the basal opioid regimen has been investigated in fentanyl buccal tablet (FBT) [ 5 , 6 ] but not FBSF. In fact, only a limited number of studies that associated with FBSF are currently available.…”

Section: Discussionmentioning

confidence: 99%

Proportional dose of rapid-onset opioid in breakthrough cancer pain management

Yen

Chiou

Chiang³

et al. 2018

Medicine

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Background:The management of breakthrough pain (BTP) in cancer patients is a challenge. It is clinically useful to evaluate the effectiveness of rapid-onset opioid at a starting dose in proportional to the background opioid regimen. This open-label, multicenter, noncomparative study aimed to assess the efficacy and safety of proportional doses of fentanyl buccal soluble film (FBSF) in patients with breakthrough cancer pain.Methods:Thirty patients aged 20 to 70, experiencing 1 to 3 BTP per day, receiving regimens equivalent to 60 to 360 mg/day of oral morphine or 25 to 150 μg/h of transdermal fentanyl ≥1 week, were prospectively recruited. FBSF was administered proportionally based on their current opioid regimen for baseline pain. The percentage of patients requiring dose titration was evaluated. For each BTP episode, changes in pain intensity at 30 minutes (PID30) after dosing, patient's satisfaction, the percentage of episodes requiring rescue medication, and adverse events (AEs) were recorded.Results:The percentage of patients who required dose titration was 21.4% (6/28) and 12.0% (3/25) in the full analysis set and per-protocol populations, respectively. The average PID30 was 3.9, and a pain score ≤3 was achieved in 95.1% of the events. Eight out of 367 (2.2%) BTP episodes needed rescue medication. The majority of subjects (75.8%) rated their experience of pain management as good to excellent. A total of 6 drug-related AEs were reported by 3 (10.7%) patients in the safety population.Conclusions:FBSF dose in proportional to the regimen of opioid for baseline pain management is efficacious and well tolerated for the treatment of cancer patients with BTP.

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A Randomized, Double-Blind, Placebo-Controlled Study of Fentanyl Buccal Tablets for Breakthrough Pain: Efficacy and Safety in Japanese Cancer Patients

Abstract: The safety of FBT and its analgesic effect on BTP were confirmed in Japanese cancer patients receiving opioids. Our findings suggest that analgesic onset may occur from 15 minutes after FBT, and that FBT can be administered to patients with low doses of ATC opioids.

Cited by 21 publications

References 22 publications

Rapid acting fentanyl formulations in breakthrough pain in cancer. Drug selection by means of the System of Objectified Judgement Analysis

Rapid acting fentanyl formulations in breakthrough pain in cancer. Drug selection by means of the System of Objectified Judgement Analysis

Breakthrough Cancer Pain: The Current Pharmacological Management

Proportional dose of rapid-onset opioid in breakthrough cancer pain management

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