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Erschienen in: Supportive Care in Cancer 3/2012

01.03.2012 | Original Article

Long-term tolerability, efficacy and acceptability of fentanyl pectin nasal spray for breakthrough cancer pain

verfasst von: Lukas Radbruch, Luis M. Torres, John E. Ellershaw, Antonio Gatti, Guillermo Luis Lerzo, Julia Revnic, Donald Taylor

Erschienen in: Supportive Care in Cancer | Ausgabe 3/2012

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Abstract

Purpose

Previous studies show that fentanyl pectin nasal spray (FPNS) rapidly provides clinically meaningful pain relief in the treatment of breakthrough cancer pain (BTCP). This study assessed the long-term tolerability, acceptability and consistency of effect of FPNS in patients with BTCP.

Methods

Patients (new and rolled over from earlier controlled studies) with cancer experiencing one to four episodes per day of BTCP whilst taking ≥60 mg/day of morphine (or equivalent) given orally for cancer pain entered an open-label 16-week safety study. Safety and tolerability were assessed by adverse events (AEs), adverse drug reactions (ADRs), withdrawal due to AEs and by nasal assessments. Acceptability assessments included ratings of overall satisfaction with each treated episode and ease of use and convenience of FPNS. Additional rescue medication and dose stability were used to evaluate the consistency of effect.

Results

Four hundred three patients were included in the safety and intent-to-treat analysis (42,227 episodes), 356 entered the treatment phase and 110 completed 16 weeks. Overall, 24.6% of 403 patients reported treatment-related treatment-emergent AEs that were generally mild/moderate and typical of opioids; 20 patients discontinued treatment due to an AE (9 were ADRs). Nasal assessments revealed no clinically significant effects; 94% of FPNS-treated episodes required no additional rescue medication. More than 90% of patients did not have to increase their dose during the study. Patients reported overall satisfaction with FPNS for 90.1% of episodes. At week 12, 96.9% of patients were satisfied with the ease of use and 97.9% with the convenience of FPNS.

Conclusions

FPNS was generally well tolerated and well accepted for the treatment of BTCP, and doses remained stable over the 4-month study period.
Literatur
1.
Zurück zum Zitat Bennett DS, Burton AW, Fishman S et al (2005) Consensus panel recommendations for the assessment and management of breakthrough pain, part 2: management. Pharm Ther 30(6):354–361 Bennett DS, Burton AW, Fishman S et al (2005) Consensus panel recommendations for the assessment and management of breakthrough pain, part 2: management. Pharm Ther 30(6):354–361
2.
Zurück zum Zitat Brennan F (2007) Palliative care as an international human right. J Pain Symptom Manage 33(5):494–499PubMedCrossRef Brennan F (2007) Palliative care as an international human right. J Pain Symptom Manage 33(5):494–499PubMedCrossRef
3.
Zurück zum Zitat Caraceni A, Martini C, Zecca E et al (2004) Breakthrough pain characteristics and syndromes in patients with cancer pain: an international survey. Palliat Med 18(3):177–183PubMedCrossRef Caraceni A, Martini C, Zecca E et al (2004) Breakthrough pain characteristics and syndromes in patients with cancer pain: an international survey. Palliat Med 18(3):177–183PubMedCrossRef
4.
Zurück zum Zitat Cherny NI, Baselga J, de Conno F, Radbruch L (2010) Formulary availability and regulatory barriers to accessibility of opioids for cancer pain in Europe: a report from the ESMO/EAPC Opioid Policy Initiative. Ann Oncol 21(3):615–626PubMedCrossRef Cherny NI, Baselga J, de Conno F, Radbruch L (2010) Formulary availability and regulatory barriers to accessibility of opioids for cancer pain in Europe: a report from the ESMO/EAPC Opioid Policy Initiative. Ann Oncol 21(3):615–626PubMedCrossRef
5.
Zurück zum Zitat Collins SL, Faura CC, Moore RA, McQuay HJ (1998) Peak plasma concentrations after oral morphine: a systematic review. J Pain Symptom Manage 16(6):388–402PubMedCrossRef Collins SL, Faura CC, Moore RA, McQuay HJ (1998) Peak plasma concentrations after oral morphine: a systematic review. J Pain Symptom Manage 16(6):388–402PubMedCrossRef
6.
Zurück zum Zitat Dale O, Hjortkjaer R, Kharasch ED (2002) Nasal administration of opioids for pain management in adults. Acta Anaesthesiol Scand 46(7):759–770PubMedCrossRef Dale O, Hjortkjaer R, Kharasch ED (2002) Nasal administration of opioids for pain management in adults. Acta Anaesthesiol Scand 46(7):759–770PubMedCrossRef
7.
Zurück zum Zitat Davies AN, Broadley K, Beighton D (2001) Xerostomia in patients with advanced cancer. J Pain Symptom Manage 22(4):820–825PubMedCrossRef Davies AN, Broadley K, Beighton D (2001) Xerostomia in patients with advanced cancer. J Pain Symptom Manage 22(4):820–825PubMedCrossRef
8.
Zurück zum Zitat Davies AN, Dickman A, Reid C, Stevens AM, Zeppetella G (2009) The management of cancer-related breakthrough pain: recommendations of a task group of the Science Committee of the Association for Palliative Medicine of Great Britain and Ireland. Eur J Pain 13(4):331–338PubMedCrossRef Davies AN, Dickman A, Reid C, Stevens AM, Zeppetella G (2009) The management of cancer-related breakthrough pain: recommendations of a task group of the Science Committee of the Association for Palliative Medicine of Great Britain and Ireland. Eur J Pain 13(4):331–338PubMedCrossRef
9.
Zurück zum Zitat Davies AN, Vriens J, Kennett A, McTaggart M (2008) An observational study of oncology patients’ utilization of breakthrough pain medication. J Pain Symptom Manage 35(4):406–411PubMedCrossRef Davies AN, Vriens J, Kennett A, McTaggart M (2008) An observational study of oncology patients’ utilization of breakthrough pain medication. J Pain Symptom Manage 35(4):406–411PubMedCrossRef
10.
Zurück zum Zitat Fallon M, Gatti A, Davies AN et al (2009) Efficacy, safety and patient acceptability of fentanyl pectin nasal spray compared with immediate-release morphine sulphate tablets in the treatment of breakthrough cancer pain: a multicentre, double-blind, double-dummy, multiple-crossover study. Eur J Cancer Supp 7:15CrossRef Fallon M, Gatti A, Davies AN et al (2009) Efficacy, safety and patient acceptability of fentanyl pectin nasal spray compared with immediate-release morphine sulphate tablets in the treatment of breakthrough cancer pain: a multicentre, double-blind, double-dummy, multiple-crossover study. Eur J Cancer Supp 7:15CrossRef
11.
Zurück zum Zitat Illum L (2003) Nasal drug delivery—possibilities, problems and solutions. J Control Release 87(1–3):187–198PubMedCrossRef Illum L (2003) Nasal drug delivery—possibilities, problems and solutions. J Control Release 87(1–3):187–198PubMedCrossRef
12.
Zurück zum Zitat Mercadante S, Radbruch L, Caraceni A et al (2002) Episodic (breakthrough) pain: consensus conference of an expert working group of the European Association for Palliative Care. Cancer 94(3):832–839PubMedCrossRef Mercadante S, Radbruch L, Caraceni A et al (2002) Episodic (breakthrough) pain: consensus conference of an expert working group of the European Association for Palliative Care. Cancer 94(3):832–839PubMedCrossRef
13.
Zurück zum Zitat Miaskowski C, Dodd MJ, West C et al (2001) Lack of adherence with the analgesic regimen: a significant barrier to effective cancer pain management. J Clin Oncol 19(23):4275–4279PubMed Miaskowski C, Dodd MJ, West C et al (2001) Lack of adherence with the analgesic regimen: a significant barrier to effective cancer pain management. J Clin Oncol 19(23):4275–4279PubMed
14.
Zurück zum Zitat Petzke F, Radbruch L, Zech D, Loick G, Grond S (1999) Temporal presentation of chronic cancer pain: transitory pains on admission to a multidisciplinary pain clinic. J Pain Symptom Manage 17(6):391–401PubMedCrossRef Petzke F, Radbruch L, Zech D, Loick G, Grond S (1999) Temporal presentation of chronic cancer pain: transitory pains on admission to a multidisciplinary pain clinic. J Pain Symptom Manage 17(6):391–401PubMedCrossRef
15.
Zurück zum Zitat Portenoy R, Bruns D, Shoemaker B, Shoemaker S (2010) Breakthrough pain in community-dwelling patients with cancer pain and noncancer pain, part 1: prevalence and characteristics. J Opioid Manag 6:97–108PubMedCrossRef Portenoy R, Bruns D, Shoemaker B, Shoemaker S (2010) Breakthrough pain in community-dwelling patients with cancer pain and noncancer pain, part 1: prevalence and characteristics. J Opioid Manag 6:97–108PubMedCrossRef
16.
Zurück zum Zitat Portenoy RK, Burton A, Gabrail N (2010) A multicenter, placebo-controlled, double-blind, multiple-crossover study of fentanyl pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain. Pain 151(3):617–624PubMedCrossRef Portenoy RK, Burton A, Gabrail N (2010) A multicenter, placebo-controlled, double-blind, multiple-crossover study of fentanyl pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain. Pain 151(3):617–624PubMedCrossRef
17.
Zurück zum Zitat Portenoy RK, Hagen NA (1990) Breakthrough pain: definition, prevalence and characteristics. Pain 41(3):273–281PubMedCrossRef Portenoy RK, Hagen NA (1990) Breakthrough pain: definition, prevalence and characteristics. Pain 41(3):273–281PubMedCrossRef
18.
Zurück zum Zitat Portenoy RK, Payne D, Jacobsen P (1999) Breakthrough pain: characteristics and impact in patients with cancer pain. Pain 81(1–2):129–134PubMedCrossRef Portenoy RK, Payne D, Jacobsen P (1999) Breakthrough pain: characteristics and impact in patients with cancer pain. Pain 81(1–2):129–134PubMedCrossRef
19.
Zurück zum Zitat Svendsen KB, Andersen S, Arnason S et al (2005) Breakthrough pain in malignant and non-malignant diseases: a review of prevalence, characteristics and mechanisms. Eur J Pain 9(2):195–206PubMedCrossRef Svendsen KB, Andersen S, Arnason S et al (2005) Breakthrough pain in malignant and non-malignant diseases: a review of prevalence, characteristics and mechanisms. Eur J Pain 9(2):195–206PubMedCrossRef
20.
Zurück zum Zitat Walker G, Wilcock A, Manderson C, Weller R, Crosby V (2003) The acceptability of different routes of administration of analgesia for breakthrough pain. Palliat Med 17(2):219–221PubMedCrossRef Walker G, Wilcock A, Manderson C, Weller R, Crosby V (2003) The acceptability of different routes of administration of analgesia for breakthrough pain. Palliat Med 17(2):219–221PubMedCrossRef
21.
Zurück zum Zitat Watts P, Smith A (2009) PecSys: in situ gelling system for optimised nasal drug delivery. Expert Opin Drug Deliv 6(5):543–552PubMedCrossRef Watts P, Smith A (2009) PecSys: in situ gelling system for optimised nasal drug delivery. Expert Opin Drug Deliv 6(5):543–552PubMedCrossRef
Metadaten
Titel
Long-term tolerability, efficacy and acceptability of fentanyl pectin nasal spray for breakthrough cancer pain
verfasst von
Lukas Radbruch
Luis M. Torres
John E. Ellershaw
Antonio Gatti
Guillermo Luis Lerzo
Julia Revnic
Donald Taylor
Publikationsdatum
01.03.2012
Verlag
Springer-Verlag
Erschienen in
Supportive Care in Cancer / Ausgabe 3/2012
Print ISSN: 0941-4355
Elektronische ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-011-1124-x

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