A comparison of intranasal fentanyl spray with oral transmucosal fentanyl citrate for the treatment of breakthrough cancer pain: an open-label, randomised, crossover trial

Mercadante, Sebastiano; Radbruch, Lukas; Davies, Andrew; Poulain, P.; Sitte, Thomas; Perkins, Paul; Colberg, T.; Camba, M. A.

doi:10.1185/03007990903336135

Cited by 153 publications

(127 citation statements)

References 30 publications

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“…The AEs judged to be related to INFS included vomiting, dizziness, fatigue and euphoric mood, all of which are commonly observed with the use of rapid onset opioid analgesics in this indication [16,42,43], as well as rhinalgia and sneezing attributable to the intranasal mode of drug delivery. The lower frequency of AEs observed in the current study, compared with those reported in controlled studies [16][17][18], may in part reflect the shorter duration of this study, as well as differences in reporting procedures and study design.…”

Section: Discussioncontrasting

confidence: 53%

“…Besides prevention, control is a key therapeutic challenge in BTcP management for affected patients, and an increasingly commonly used strategy is the administration of fast-acting (rapid onset) fentanyl preparations on demand basis, from which INFS seems to pharmacologically mirror the rapid onset and short duration of BTcP episodes better than older transmucosal therapies [18].…”

Section: Discussionmentioning

confidence: 99%

“…According to the definitions given by Farrar et al [40], INFS has previously been shown in patients with BTcP to produce clinically important/significant pain relief (i.e. ≥30% PI reduction/>2 PI difference in comparison to the situation prior use) as early as 5-10 minutes post-administration [16,18].…”

Section: Discussionmentioning

confidence: 99%

“…This special formulation has been evaluated extensively in the restricted setting of placebo- [16,17] and even active-controlled clinical trials [18], having demonstrated not only a rapid onset of action (median 7 minutes) for the relief of dental post-operative pain [38], but for INFS at doses of 50-200 µg, a significantly faster (onsetofactivityat10 min) and more effective treatment when compared with placebo [16], as well as a significantly greater pain relief (from5minutes post dosing) and faster meaningful pain relief than OTFC [18].…”

Section: Discussionmentioning

confidence: 99%

“…Due to clinical studies, INFS constitutes a promising new treatment approach for BTcP, having demonstrated not only clinically important analgesic efficacy within 10 minutes post-administration as well as a favorable safety/tolerability profile in two randomized, placebo-controlled trials [16,17], but even a superior analgesic efficacy in comparison to oral transmucosal fentanyl citrate (OTFC) during a randomized active controlled cross-over trial in cancer patients suffering from BTcP [18].…”

mentioning

confidence: 99%

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Efficiency of Intranasal Fentanyl in Patients with Breakthrough Cancer Pain in Daily Practice - Results of the German Non-Interventional Study with Instanyl® (GENISIS)

Ueberall¹

2014

Glob J Anesth

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Objective: Breakthrough cancer pain (BTcP) affects 19-95% of cancer patients (dependent on the definition and methods used and the populations studied) and is associated with detrimental physical, psychological and social complications in affected individuals as well as with significant economic burden on society and the healthcare system. This study evaluated the analgesic efficacy and safety of intranasal fentanyl spray (INFS) for the treatment of BTcP in a clinical setting with a special focus on its impact on health care resource utilization. Research design and methods:This was a prospective, open-label, noninterventional, multi-center study. Opioid-tolerant adult patients with BTcP received INFS in the course of routine clinical practice, and completed standardized questionnaires as well as BTcP diaries over a 28-day observation period. Clinical trial registration: ClinicalTrials.gov Identifier: NCT00994760Main outcome measures: Efficacy was assessed using measures of BTcP intensities, the times to first and to the maximum effect of INFS, as well as changes in BTcP-related restrictions in quality-of-life (QoL), activities of daily life (ADL) and overall wellbeing. Further analyses based on INFS-related changes in health care resource utilization. Treatment emergent adverse events (TEAEs) were recorded throughout.Results: Overall, 58 centers participated and enrolled 131 patients, of whom 116 (88.5%) completed the observation period and documented a total of 556BTcP episodes. The 100µg dose was judged as the most effective INFS dose in 64.0a% of patients, followed by 50 µg (28.0a%) and 200 µg (8.0 a%). The study recorded a substantial INFSrelated improvement in maximum BTcP intensity, compared with baseline as well as prior use. Patients reported experiencing the first effects of the study drug within 5 minutes of administration in 81.9% of episodes, and a time to maximum effect within 10 minutes in 81.4% of episodes. QoL and BTcP-related restrictions in ADL showed considerable improvements during the observation period. INFS was well tolerated, with sixpatients (4.6%) experiencing ≥1 study drug-related adverse event. Study limitations include a modest size and duration, and the single-arm design. Conclusion:Under the conditions of this non-interventional open-label study, INFS proved to be a rapid onset, highly effective and well tolerated alternative for the treatment of BTcP in opioid-tolerant cancer patients. INFS treatment was not only associated with substantial improvements in BTcP intensity as well as related restrictions in QoL and ADL, but also with a respectable decrease of health care resource demands -especially in the field of ambulatory palliative care nursing services.relatively stable and adequately controlled background pain [2]. Due to epidemiological studies, BTcP is a common cancer complication with reported prevalence rates ranging between 19-95% (dependent on the definition and methods used, and the populations studied) [3][4][5][6][7], which is accompanied by detrimental rest...

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