Patient Satisfaction with Fentanyl Sublingual Spray in Opioid‐Tolerant Patients with Breakthrough Cancer Pain

Rauck, Richard; Parikh, Neha; Dillaha, L.; Barker, J.; Stearns, Lisa

doi:10.1111/papr.12225

Cited by 6 publications

(7 citation statements)

References 22 publications

(27 reference statements)

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“…A total of 130 patients were enrolled in the study (Table ) . and 98 (75.4%) patients completed the open‐label titration phase.…”

Section: Resultsmentioning

confidence: 99%

“…and 98 (75.4%) patients completed the open‐label titration phase. Thirty‐two patients (24.6%) discontinued participating in the study due to either an inability to determine a successful dose ( n = 3; 2.3%), intercurrent illness or surgery ( n = 1; 0.8%), an AE ( n = 6; 4.6%), a protocol violation ( n = 2; 1.5%), an investigator ( n = 2; 1.5%), patient decision ( n = 15; 11.5%), or other reason ( n = 3; 2.3%) …”

Section: Resultsmentioning

confidence: 99%

“…Of the 98 patients (75.4%) who completed the open‐label titration phase, 58.2% attained a successful dose between 800 and 1,600 mcg, and 73.5% attained an effective dose of ≥ 600 mcg (Table ) . The median successful dose of fentanyl sublingual spray was 800 mcg . For the 8 patients who had previously used an oral transmucosal fentanyl product to treat BTCP, 6 (75.0%) achieved a successful dose of fentanyl sublingual spray (the other 2 patients withdrew from the study).…”

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

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

Rauck

Bull

Parikh³

et al. 2015

Pain Practice

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“…A total of 130 patients were enrolled in the study (Table ) . and 98 (75.4%) patients completed the open‐label titration phase.…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

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

Rauck

Bull

Parikh³

et al. 2015

Pain Practice

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“…Similar to the findings in Rauck et al, fentanyl sublingual spray measured an increase in TSQM score from baseline to end of titration in all four domains. 36 However, it should be noted that the retrospective design of this analysis may have introduced recall bias. Some studies have shown that patients have a preference for transmucosal or sublingual routes of administration.…”

Section: Patient Acceptability and Preferencementioning

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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“…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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Patient Satisfaction with Fentanyl Sublingual Spray in Opioid‐Tolerant Patients with Breakthrough Cancer Pain

Abstract: These data indicate markedly improved satisfaction among patients receiving fentanyl sublingual spray relative to previous BTCP medications.

Cited by 6 publications

References 22 publications

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

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

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

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

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