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

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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.

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Acknowledgements

This study was sponsored by Archimedes Development Ltd. The authors wish to acknowledge i3Research, which conducted the study, and the technical and editorial support provided by Anita Chadha-Patel and ApotheCom.

Conflict of interest

None of the authors has any financial relationships to disclose related to this research.

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Authors and Affiliations

  1. Klinik für Palliativmedizin, Universitätsklinikum Bonn, Sigmund-Freud-Str. 25, 53127, Bonn, Germany

    Lukas Radbruch

  2. Hospital Puerta del Mar, Avenida Ana de Viya 21, 11009, Cádiz, Spain

    Luis M. Torres

  3. Marie Curie Palliative Care Institute, Speke Road, L25 8QA, Liverpool, UK

    John E. Ellershaw

  4. Azienda Policlinico Tor Vergata, AFA Emergenza Urgenza Terapia Intensiva e Terapia del Dolore, Viale Oxford 81, Rome, 00133, Italy

    Antonio Gatti

  5. Investigaciones Medicas Buenos Aires, Estado de Israel 4718, Buenos Aires, 1185, Argentina

    Guillermo Luis Lerzo

  6. Centre de Soins Palliatifs et Traitement de la Douleur, Hôtel-Dieu, 1 Place du Parvis Notre-Dame, 75004, Paris, France

    Julia Revnic

  7. Comprehensive Pain Care, PC, Taylor Research, LLC, 840 Church Street NE, Marietta, GA, 30060, USA

    Donald Taylor

Authors
  1. Lukas Radbruch
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  2. Luis M. Torres
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  3. John E. Ellershaw
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  4. Antonio Gatti
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  5. Guillermo Luis Lerzo
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  6. Julia Revnic
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  7. Donald Taylor
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Corresponding author

Correspondence to Lukas Radbruch.

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Radbruch, L., Torres, L.M., Ellershaw, J.E. et al. Long-term tolerability, efficacy and acceptability of fentanyl pectin nasal spray for breakthrough cancer pain. Support Care Cancer 20, 565–573 (2012). https://doi.org/10.1007/s00520-011-1124-x

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  • DOI: https://doi.org/10.1007/s00520-011-1124-x

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