Long-term safety of fentanyl sublingual spray in opioid-tolerant patients with breakthrough cancer pain

Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer
Harold MinkowitzR Rauck

Abstract

The current study assessed the long-term safety of fentanyl sublingual spray for managing breakthrough cancer pain (BTCP). This open-label, multicenter study enrolled both de novo and rollover patients who completed a double-blind, efficacy trial. Eligible patients were ≥18 years of age and experiencing pain that was being managed with an around-the-clock opioid yet were experiencing ≤4 BTCP episodes daily and were opioid-tolerant (i.e., receiving ≥60 mg/day oral morphine or an equivalent dose of another opioid for ≥1 week). De novo patients initially entered a 21-day titration period to identify an effective dose of fentanyl sublingual spray (100-1600 μg), then entered a 90-day maintenance period. The incidence of adverse events (AEs), results of laboratory tests, vital sign assessments, and treatment satisfaction were assessed. Of the 269 patients (de novo, 179; rollover, 90) who entered the maintenance period, 163 (60.6 %) completed the study; the primary reason for discontinuation was an AE (22.3 %). Eighty percent of patients identified an effective dose of fentanyl sublingual spray (median dose, 600 μg). The most common AEs differed from the titration period (nausea (13 %), vomiting (12 %), and somnolence (10 %)) to the m...Continue Reading

References

Sep 16, 2000·Journal of Pain and Symptom Management·G ZeppetellaS Collins
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Jun 17, 2004·Palliative Medicine·Augusto CaraceniUNKNOWN Working Group of an IASP Task Force on Cancer Pain
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Jul 30, 2011·Expert Review of Neurotherapeutics·Mellar P Davis
Jun 26, 2013·Journal of Pain and Symptom Management·Silvia DeandreaGiovanni Apolone

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Citations

Mar 25, 2017·Drugs·Stephan A Schug, Sonya Ting

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