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Supportive Oncology Breakthrough Cancer Pain A New Fast-acting Sublingual Fentanyl (Recivit ® ) for Treating Breakthrough Cancer Pain Andrew Davies Consultant in Palliative Medicine, Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK Abstract Cancer pain presents a significant clinical challenge. Even when background pain is effectively controlled, patients often experience episodes of breakthrough cancer pain (BTcP), which typically reach maximum intensity in 10 minutes and last for 60 minutes. Immediate-release opioids are often used to treat BTcP, but only produce analgesia after 20–30 minutes and their full analgesic effect after 60–90 minutes, so transmucosal formulations of fentanyl citrate have been developed that produce analgesia more rapidly. A new sublingual transmucosal formulation (the FE tablet) utilises a unique three-layer structure and is available in dosages from 67  µg to 800  µg. This review summarises available data on the new formulation. In phase I trials, it has demonstrated dose proportionality, absolute bioavailability of approximately 70  % and higher plasma fentanyl concentrations than an oral transmucosal fentanyl citrate lozenge. In a prospective, randomised, double-blind, crossover study to evaluate efficacy and safety, pain relief was recorded from 6 minutes after administration onwards and lasted for up to 60 minutes. Keywords Breakthrough pain, analgesia, fentanyl citrate, transmucosal formulation, FE tablet Disclosure: Andrew Davies has received an honorarium for attending an associated advisory board from Grünenthal GmbH. Received: 5 February 2014 Accepted: 7 May 2014 Citation: European Oncology & Haematology, 2014;10(1):12–6 Correspondence: Andrew Davies, Royal Surrey County Hospital/St Luke’s Cancer Centre, Egerton Road, Guildford, Surrey GU2 7XX, UK. E: adavies12@nhs.net Support: The publication of this article was supported by Grünenthal GmbH. The views and opinions expressed are those of the author and not necessarily those of Grünenthal GmbH. Pain is a common feature of cancer that presents a significant clinical challenge. The prevalence of pain increases as the condition progresses 1 and it affects over 80 % of patients with advanced disease. 2 Opioids remain the best front-line treatment for providing pain relief (PR), but even when these agents effectively control background pain, patients often experience breakthrough cancer pain (BTcP). 3 This may be defined as ‘a transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain’. 4 procedure such as wound dressing). 4 Episodes of pain that occur shortly before the administration of ‘around-the-clock’ (ATC) opioid analgesics (‘end of dose failure’) should not be regarded as BTcP, since the background pain is not controlled in this situation. BTcP is a heterogeneous entity that varies both between individuals and within individuals over time. 5 In a recent study that enrolled 1,000 European oncology patients, the median number of BTcP episodes was three per day, with >95 % of subjects rating the intensity of pain as either ‘moderate’ or ‘severe’. 6 Median time to peak intensity was 10  minutes, and the median duration of episodes was 60 minutes. 6 The negative effect on quality of life can be significant, as a result of personal suffering and interference with the activities of daily living. 6 Management of Breakthrough Cancer Pain BTcP may be classified as either spontaneous pain (episodes are unpredictable and not related to an identifiable precipitant) or incident pain (episodes are related to a specific identifiable precipitant). 4 There are three sub-classifications of incident pain: volitional (brought on by a voluntary act such as movement), non-volitional (brought on by an involuntary act such as coughing) and procedural (related to a therapeutic 12 This review article summarises the available data on a new fast-acting fentanyl formulation for treating breakthrough pain, which has been developed to accelerate absorption of fentanyl and reduce the time to onset of analgesia. There is currently no ‘gold standard’ for the pharmacological symptomatic treatment of BTcP, but the most common strategy is the use of supplemental analgesia, or ‘rescue medication’. 4 The ideal rescue medication should not only be safe and effective, but also have a rapid onset of action, a relatively short duration of effect 7 and be suitable for use both reactively (i.e. at the onset of pain) and prophylactically (i.e. prior to the onset of pain in patients with predictable incident pain). These properties would enable BTcP to be rapidly controlled, while avoiding opioid accumulation and minimising adverse effects. 8 Currently, BTcP is widely treated with supplemental doses of oral opioids – often immediate-release formulations of morphine. The time to onset of analgesia for these agents is 20–30 minutes, and the time to full effect 60–90 minutes. 4 This is not ideal for managing many BTcP episodes. © TOUC H ME D IC AL ME D IA 2014