Long-Term Safety and Tolerability of Fentanyl Buccal Tablet for the Treatment of Breakthrough Pain in Opioid-Tolerant Patients with Chronic Pain: An 18-Month Study

Fine, Perry G.; Messina, John; Xie, Fang; Rathmell, James P.

doi:10.1016/j.jpainsymman.2010.02.009

Cited by 40 publications

(46 citation statements)

References 23 publications

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“…The most common adverse events are nausea, dizziness, and vomiting 56. Application-site abnormalities have been reported by 5%–15% of patients in clinical studies of FBT, but are mainly transient and mild to moderate in severity 50,52–57…”

Section: Fentanyl and Fentanyl Formulationsmentioning

confidence: 99%

“…In a study comparing FBT with immediate-release oxycodone, FBT was preferred by 52% of patients compared with 33% for oxycodone 55. Similarly in a comparison of FBT with previous traditional short-acting opioids (eg, oral morphine, oxycodone, or hydrocodone), more patients reported that they preferred FBT to their previous BTP medication,57 stating reasons such as speed of action, convenience, and ease of administration of FBT 57…”

Section: Considerations When Selecting Rapid-onset Opioids For Breaktmentioning

confidence: 99%

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Considerations in selecting rapid-onset opioids for the management of breakthrough pain

Smith¹

2013

JPR

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Breakthrough pain (BTP) is a transitory pain that occurs despite the use of long-term, around-the-clock analgesia. It is highly prevalent in certain populations and places a significant burden on patients, their families, caregivers, and health-care systems. Despite its prevalence and impact, BTP is sometimes unrecognized and often undertreated. Various formulations of fentanyl – a rapid-onset opioid with short duration of action – are available for the management of BTP. The efficacy of formulations using transmucosal, transbuccal, sublingual, and intranasal administration routes has been demonstrated for BTP treatment in clinical trials. However, a lack of head-to-head trials evaluating their relative efficacy makes it challenging for physicians to reach informed decisions on the most efficacious intervention for individual patients. In the absence of clear data on the relative efficacy of fentanyl formulations, prescribing decisions need to be based on physician understanding and experience and product cost and availability, taking into account the individual patient’s needs, the ability of the patient or caregivers to administer medication, and the patient’s wishes. This review evaluates current pharmacologic methods of alleviating BTP and discusses factors that should be considered when selecting the most appropriate formulation for individual patients. With the range of fentanyl formulations available, it is now possible to successfully address BTP in the majority of patients.

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Section: Fentanyl and Fentanyl Formulationsmentioning

confidence: 99%

Section: Considerations When Selecting Rapid-onset Opioids For Breaktmentioning

confidence: 99%

Considerations in selecting rapid-onset opioids for the management of breakthrough pain

Smith¹

2013

JPR

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“…[74] Application-site abnormalities were reported by 5–15% of patients in clinical studies of FBT but were predominantly transient and mild to moderate in severity. [20–24,74,75]…”

Section: Current Treatments For Btpmentioning

confidence: 99%

A Comprehensive Review of Rapid-Onset Opioids for Breakthrough Pain

Smith

2012

CNS Drugs

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Breakthrough pain (BTP) is a transitory pain (reaching maximum severity in ∼15 minutes and lasting ∼60 minutes in patients with cancer) that occurs despite the management of chronic pain with long-term around-the-clock analgesia. BTP occurs in 33–65% of patients with chronic cancer pain and in ∼70% of patients with chronic noncancer pain. BTP has historically been managed with short-acting opioids; however, these medications have a pharmacokinetic profile that does not correlate with the sudden onset and short time to maximum severity of BTP. Interest in rapid-onset opioids to relieve BTP has therefore been growing. This comprehensive review aims to summarize the currently available clinical data for the approved rapid-onset opioids, which comprise different formulations of fentanyl, a μ-opioid receptor agonist with anaesthetic and analgesic properties. Administration routes for fentanyl in the management of BTP currently include the transmucosal and intranasal routes; an intrapulmonary formulation is also in development. The findings of this review suggest that the efficacy and safety of the approved rapid-onset opioids are comparable.

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“…In both long-term studies, patient withdrawal due to treatment adverse effects was less than 2%. 65,80 …”

Section: Fentanyl Buccal Formulationsmentioning

confidence: 99%

Transmucosal Immediate-Release Fentanyl for Breakthrough Cancer Pain: Opportunities and Challenges for Use in Palliative Care

Chang¹,

Roeland²,

Atayee³

et al. 2015

Journal of Pain & Palliative Care Pharmacotherapy

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Opioids are used to treat breakthrough cancer pain (BTCP) and can be classified by relative duration and onset of action. Regulatory approvals of numerous transmucosal immediate-release fentanyl (TIRF) formulations provide alternative options to palliative care-trained providers in the management of BTCP. TIRFs have been formulated as a sublingual tablet, sublingual spray, intranasal spray, pectin-based nasal spray, buccal tablet, and buccal soluble film. Differences exist between TIRFs regarding formulation design and dosing to treat BTCP. Opportunities for use include palliation of BTCP in head and neck cancer and/or radiation-induced mucositis. The purpose of this review is to discuss TIRF formulation and dosing, pharmacokinetics, clinical efficacy, patient acceptability, and safety/tolerability. In addition, barriers to TIRF utilization will be discussed.

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Long-Term Safety and Tolerability of Fentanyl Buccal Tablet for the Treatment of Breakthrough Pain in Opioid-Tolerant Patients with Chronic Pain: An 18-Month Study

Abstract: FBT was generally safe and well tolerated, with self-reported functional improvement observed in most of the opioid-tolerant patients with BTP in association with chronic noncancer pain.

Cited by 40 publications

References 23 publications

Considerations in selecting rapid-onset opioids for the management of breakthrough pain

Considerations in selecting rapid-onset opioids for the management of breakthrough pain

A Comprehensive Review of Rapid-Onset Opioids for Breakthrough Pain

Transmucosal Immediate-Release Fentanyl for Breakthrough Cancer Pain: Opportunities and Challenges for Use in Palliative Care

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