Effective Dose Titration of Fentanyl Sublingual Spray in Patients With Breakthrough Cancer Pain

Rauck, Richard; Bull, Janet; Parikh, Neha; Dillaha, L.; Stearns, Lisa

doi:10.1111/papr.12360

Cited by 4 publications

(2 citation statements)

References 23 publications

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“…As well, a fentanyl sublingual spray formulation administered for BTCP has been shown to be efficacious and well tolerated [20][21][22][23] and produce a significantly greater reduction in pain intensity versus placebo as early as 5 min after dosing, with a duration of 60 min (the last time interval assessed) [20]. A sublingual administration route may provide more rapid onset of action versus other BTCP treatment routes of administration because of the high permeability and more available blood supply to the sublingual cavity relative to the oral route [24].…”

Section: Practice Pointsmentioning

confidence: 99%

Fentanyl sublingual spray for breakthrough cancer pain in patients receiving transdermal fentanyl.

Alberts

Rauck

Parikh³

et al. 2014

JCO

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aim: To investigate the relationship between effective fentanyl sublingual spray (FSS) doses for breakthrough cancer pain (BTCP) and around-the-clock (ATC) transdermal fentanyl patch (TFP). Methods: Adults tolerating ATC opioids received open-label FSS for 26 days, followed by a 26-day double-blind phase for patients achieving an effective dose (100-1600 μg). Results: Out of 50 patients on ATC TFP at baseline, 32 (64%) achieved an effective dose. FSS effective dose moderately correlated with mean TFP dose (r = 0.4; p = 0.03). Patient satisfaction increased during the study. Common adverse events included nausea (9%) and peripheral edema (9%). conclusion: FSS can be safely titrated to an effective dose for BTCP in patients receiving ATC TFP as chronic cancer pain medication. clinicaltrials.gov identifier: NCT00538850 Keywords• breakthrough cancer pain • fentanyl sublingual spray • transmucosal immediate-release fentanyl David S Alberts, MD, and co-authorsPersistent underlying pain in patients with cancer is effectively managed by around-the-clock (ATC) opioid analgesics; however, transient exacerbations of pain that occur spontaneously over the underlying pain, commonly described as breakthrough cancer pain (BTCP), can occur [1,2]. BTCP is reported by 15-100% of patients with cancer depending on the clinical setting and patient population studied [3][4][5][6][7][8][9]. In a systematic review of 19 observational Practice points• Patients with cancer-related pain may require around-the clock (ATC) opioid analgesics.• Despite ATC opioids, breakthrough cancer pain (BTCP) may necessitate the use of additional analgesics.• Fentanyl products such as the transdermal fentanyl patch and fentanyl sublingual spray may be prescribed to manage BTCP.• Treatment of cancer-related pain is complex and requires thorough understanding of the relationship between doses of concomitant medications and their analgesic and adverse effects.• The current study indicates a weak-to-moderate correlation between the effective dose of fentanyl sublingual spray used to treat BTCP and the effective dose of ATC transdermal fentanyl patch.• Initiating treatment with a low dose of a fentanyl sublingual spray and titrating upward to identify an effective dose may be an efficacious strategy for patients receiving ATC transdermal fentanyl patch and fentanyl sublingual fentanyl spray.• Fentanyl sublingual spray is generally well tolerated in patients receiving ATC transdermal fentanyl patch for BTCP.Pain Manag. (Epub ahead of print)

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Section: Practice Pointsmentioning

confidence: 99%

Fentanyl sublingual spray for breakthrough cancer pain in patients receiving transdermal fentanyl.

Alberts

Rauck

Parikh³

et al. 2014

JCO

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“…The suitability of telephone assessments for the titration of drugs for BTcP control (such as fentanyl) has already been described in the literature [32,33]. However, various aspects led to non-consensus, such as the availability of personnel to perform this task, the need to carefully select the appropriate The main strength of this study is the fact that it is based on responses (response rate: fi rst round 97.8%, second round 100%) from a national panel of experts.…”

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confidence: 99%

Breakthrough cancer pain: A delphi consensus study on expert recommendations for barriers that prevent the proper management of BTcP in Spain

Álvarez¹,

Espinosa²,

Salcedo³

et al. 2020

Open J Pain Med

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Background: The management of Breakthrough cancer Pain (BTcP) remains unsatisfactory. Although many barriers to BTcP management have been identifi ed, oncologists have not been able to overcome them. The aim of this study is to identify the barriers preventing proper BTcP management that Spanish medical oncologists have found, and to reach a consensus in order to draft the appropriate recommendations to overcome them. Methods: This study is based on two surveys conducted by oncologists. The fi rst survey was designed to reach a consensus on the main barriers (related to patients, physicians and healthcare organizations) that stand in the way of BTcP control. The second survey (a Delphi questionnaire) was based on the barriers evaluated in the fi rst survey, including recommendations assessed using the two-round Delphi methodology. Results: The identifi cation of the main barriers to BTcP management to be assessed showed a high consensus regarding the need for greater involvement from health organizations. Eighty-eight experienced oncologists evaluated the proposed recommendations. A consensus was reached on 93% of these recommendations, always in terms of agreement. Only three recommendations did not reach a consensus, one in each block of barriers (patients, physicians and healthcare organizations). Conclusion: Showing a high degree of consensus, the results of this study refl ect that there are overworked medical oncologists, which results in more time and training being taken away from proper BTcP management. Although oncologists considered cancer pain management to be suitable in oncologist consultations, they also revealed that more support and resources are necessary in order to improve BTcP control.

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Fentanyl Formulations in the Management of Pain: An Update

Schug

Ting

2017

Drugs

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Fentanyl is a synthetic, highly selective opioid with many desirable physicochemical properties, including a high lipophilicity and predictable pharmacokinetics. These properties have an established record in the management of pain in a variety of settings, particularly acute pain and breakthrough cancer pain. Fentanyl was initially developed for parenteral use; however, this is invasive and impractical in the outpatient setting. Unfortunately, the high first-pass metabolism of fentanyl makes oral formulations unfeasible. However, its high lipophilicity allows fentanyl to be absorbed via a number of other routes. Thus new formulations were designed to allow non-invasive methods of administration. Transmucosal and transdermal fentanyl formulations are well established, and have proven useful in the settings of breakthrough cancer pain, emergencies and in the paediatric population. The iontophoretic transdermal system was developed to provide a needle-free system of delivering bolus doses of fentanyl on demand, a novel way of delivering patient-controlled opioid analgesia. Transpulmonary administration of fentanyl remains experimental. The aim of this review is to provide an update on current non-parenteral fentanyl formulations, with attention to their particular pharmacokinetics and features relevant to clinical use in pain management.

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Effective Dose Titration of Fentanyl Sublingual Spray in Patients With Breakthrough Cancer Pain

Abstract: In patients with BTCP, fentanyl sublingual spray can be rapidly and safely titrated to an effective dose, resulting in greater satisfaction with fentanyl sublingual spray than previous BTCP medications.

Cited by 4 publications

References 23 publications

Fentanyl sublingual spray for breakthrough cancer pain in patients receiving transdermal fentanyl.

Fentanyl sublingual spray for breakthrough cancer pain in patients receiving transdermal fentanyl.

Breakthrough cancer pain: A delphi consensus study on expert recommendations for barriers that prevent the proper management of BTcP in Spain

Fentanyl Formulations in the Management of Pain: An Update

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