Efficacy, safety, and tolerability of fentanyl pectin nasal spray in patients with breakthrough cancer pain

Ueberall, Michael A; Lorenzl, Stefan; Lux, Eberhard A.; Voltz, Raymond; Perelman, Michael

doi:10.2147/jpr.s106177

Cited by 14 publications

(8 citation statements)

References 30 publications

(39 reference statements)

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“…For tolerability and ease of use, 90% and 88% of patients respectively were "satisfied" or "very satisfied" with FPNS at least once, and 87% (95% CI 81-93%) of all the patient assessments were positive for both parameters. These high rates of satisfaction are consistent with previous findings: in a recent study conducted in German palliative care centers, FPNS received a rating of "very good" or "good" for tolerability from 87% of cancer patients; 28 ease of use had a positive satisfaction evaluation in previous studies in up to 77% of patients. 13,16 All these results were also corroborated by the small number of FPNS discontinuations due to adverse events or perceived inefficacity (10%) during the radiotherapy period.…”

Section: Discussionsupporting

confidence: 90%

“…FPNS showed an acceptable safety profile, similar to that observed in previous controlled clinical trials, 13,16 and in a recent German non-interventional study: 28 events related to FPNS were typical of opioids and none of them were serious. The rate of treatment withdrawal due to adverse events (6%) was in accordance with the 5% already reported in a previous clinical trial.…”

Section: Discussionsupporting

confidence: 84%

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<p>Patient Satisfaction with Fentanyl Pectin Nasal Spray in Breakthrough Cancer Pain Management During Radiotherapy for Head and Neck Cancer</p>

Pointreau¹,

Bensadoun²,

Béra³

et al. 2020

PPA

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The severity of breakthrough cancer pain (BTcP) impacts patients' quality of life, increases the risk of anxiety and depression, lowers functional capacities, and may lead to poor compliance with cancer treatments. The aim of the current study was to assess, in a real-life setting, patient satisfaction with a fentanyl-pectin-nasal-spray (FPNS) for BTcP management in head and neck (H&N) cancer patients treated by radiotherapy. Materials and Methods: This non-interventional, prospective study was conducted in 92 adult H&N-cancer patients undergoing radiotherapy and who started FPNS treatment for BTcP. Throughout the radiotherapy period, the patients completed self-diaries to assess their BTcP episodes, FPNS use, satisfaction on FPNS efficiency (primary outcome), tolerability and ease of use. Results: Prior to FPNS treatment, 86% of the patients were experiencing ≤4 BTcP episodes/day. During the radiotherapy period, the BTcP episodes were treated with a median dose of 100µg of FPNS. Patients were "satisfied/very-satisfied" with the efficiency (73% of assessments), ease of use (87% of assessments) and tolerability (87% of assessments) of FPNS. In total, 27% of patients reported at least one adverse event related to FPNS and 4% of patients discontinued treatment due to adverse events. None of the adverse events were serious. Patient quality of life was maintained throughout the radiotherapy period. Conclusion: This study showed, in a real-life setting, that a clear majority of H&N cancer patients treated with FPNS for BTcP throughout radiotherapy expressed satisfaction with this analgesic treatment.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionsupporting

confidence: 84%

<p>Patient Satisfaction with Fentanyl Pectin Nasal Spray in Breakthrough Cancer Pain Management During Radiotherapy for Head and Neck Cancer</p>

Pointreau¹,

Bensadoun²,

Béra³

et al. 2020

PPA

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“…The mucoadhesive potential of pectin with low degree of esterification may be due to associations by hydrogen bonding between pectin free acid groups and mucin in aqueous medium and thought adsorption mechanism of pectin on the mucin molecule [ 186 ]. Pectin has been proved as nasal spray to improve the analgesic onset, treatment efficacy and acceptability to treat cancer pain, where a rapid drug release is requested [ 187 , 188 , 189 ].…”

Section: Potential Applications Of Pectin In Pharmaceutical and Bimentioning

confidence: 99%

Pectin and Pectin-Based Composite Materials: Beyond Food Texture

et al. 2018

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Pectins are plant cell wall natural heteropolysaccharides composed mainly of α-1-4 d-galacturonic acid units, which may or may not be methyl esterified, possesses neutral sugars branching that harbor functional moieties. Physicochemical features as pH, temperature, ions concentration, and cosolute presence, affect directly the extraction yield and gelling capacity of pectins. The chemical and structural features of this polysaccharide enables its interaction with a wide range of molecules, a property that scientists profit from to form new composite matrices for target/controlled delivery of therapeutic molecules, genes or cells. Considered a prebiotic dietary fiber, pectins meetmany regulations easily, regarding health applications within the pharmaceutical industry as a raw material and as an agent for the prevention of cancer. Thus, this review lists many emergent pectin-based composite materials which will probably palliate the impact of obesity, diabetes and heart disease, aid to forestall actual epidemics, expand the ken of food additives and food products design.

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“…The pectin nasal spray was well tolerated in a German study in a population of 225 subjects with BTP in cancer. 94 …”

Section: Side Effectsmentioning

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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Efficacy, safety, and tolerability of fentanyl pectin nasal spray in patients with breakthrough cancer pain

Cited by 14 publications

References 30 publications

<p>Patient Satisfaction with Fentanyl Pectin Nasal Spray in Breakthrough Cancer Pain Management During Radiotherapy for Head and Neck Cancer</p>

<p>Patient Satisfaction with Fentanyl Pectin Nasal Spray in Breakthrough Cancer Pain Management During Radiotherapy for Head and Neck Cancer</p>

Pectin and Pectin-Based Composite Materials: Beyond Food Texture

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

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