Commentary
Fentanyl pectin nasal spray for breakthrough cancer pain Luis M Torres, Jose M Trinidad, Enrique Calderón, Diego Benitez and Michael Perelman
© 2015 MA Healthcare Ltd
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atients with cancer frequently experience pain. In some patients, this is a chronic pain that is best managed by long-acting analgesia, but in many cases—23% to 93% depending on the clinical setting (Portenoy and Hagan, 1990; Portenoy et al, 1999; Greco et al, 2011)—that chronic pain is interspersed with episodes of acute and severe pain despite regular background analgesia. This pain, referred to as breakthrough cancer pain (BTCP), typically has a rapid onset, peaking within 3–5 minutes of onset, and lasts on average 30 minutes (Portenoy et al, 1999; Zeppetella et al, 2000; Abernethy et al, 2008; Caraceni et al, 2012a). BTCP can significantly impact function and quality of life; it contributes to psychological distress and morbidity, and results in an increased burden on caregivers, social networks, and health-care systems (Portenoy et al, 1999; Fortner et al, 2002; Zeppetella, 2009). Because of the episodic nature of BTCP, it is not optimally managed by increasing the dose of the long-acting analgesic, typically an opioid. Instead, international guidelines (Davies et al, 2009; Caraceni et al, 2012b) recommend adding a short-acting opioid to the background long-acting opioid, either when the BTCP episode is starting, or even more beneficially, when the patient can anticipate the appearance of the BTCP based on activities of daily living. A number of ‘so called’ short-acting opioids, such as oral immediate-release morphine sulfate (IRMS), have been used to manage BTCP (Davies et al, 2009) but their typically slow onset fails to provide early pain relief. In fact, their kinetics suggest that their onset of action is unlikely to occur until after the pain is naturally subsiding (Portenoy et al, 1999; Zeppetella et al, 2000; Abernethy et al, 2008; Caraceni et al, 2012a). Furthermore, the long duration of action often seen with such short-acting opioids may increase the risk of side-effects (Bennett et al, 2005; Zeppetella, 2008; Zeppetella, 2009; Vissers et al, 2010; Kress, 2010). In a survey of 320 patients with BTCP, the
International Journal of Palliative Nursing 2015, Vol 21, No 3
two most important characteristics of a treatment for BTCP were ‘relieves pain completely’ (47%) and ‘relieves pain quickly’ (44%) (Davies et al, 2011), which suggests that what is really needed is a treatment that is quickly absorbed, offering the potential for an early onset of pain relief, which in turn, would likely provide a superior overall relief of pain.
Experience with PecFent A number of products deliver fentanyl, a potent opioid, transmucosally; most deliver fentanyl to the mouth for absorption through the oral mucosa, but all such products are hampered by swallowing, which can not only delay the availability of up to 50% of the administered fentanyl, but also subject the delayed fentanyl to first-pass metabolism. Fentanyl Pectin Nasal Spray (FPNS; PecFent), is a novel formulation of fentanyl that instead delivers the fentanyl to the nasal mucosa and because of its pectin-based formulation reduces the likelihood of either forwards or backwards drip (Castille et al, 2013) with a resulting improvement in bioavailability (Fisher et al, 2010). PecFent was approved in Europe in 2010 for the management of BTCP in adults based on three Phase 3 trials, which included two active comparator trials (Portenoy et al, 2010; Taylor et al, 2010) and one longer term observation trial [reference]. PecFent is supplied in a device that delivers a spray of either 100 mcg or 400 mcg of fentanyl into the nasal cavity; that allows (using one or two sprays) doses ranging from 100 to 800 mcg; the device holds sufficient fentanyl to deliver eight sprays which makes it very practical for a patient to carry with them for use as needed. The two comparator trials demonstrated that FPNS not only provided superior pain relief compared with placebo (Portenoy et al, 2010; Taylor et al, 2010) but that it also proved superior to IRMS in a head to head comparison (Davies et al, 2011; Fallon et al, 2011). Across those studies, FPNS provided an onset of pain relief as early as
Luis M Torres, Head of Anesthesia, Critical Care and Pain Treatment Department; Jose M Trinidad, Medical Doctor, specialist in anesthesiology; Enrique Calderón, Medical Doctor, specialist in anesthesiology; Diego Benitez, Medical Doctor, specialist in anesthesiology, are all situated at Puerta del Mar University Hospital, Cádiz, Spain; M Perelman, Chief Medical Officer, Archimedes Development Ltd, Nottingham, UK Correspondence to: Luis M Torres
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Commentary
5 minutes (change in pain intensity) as well as an overall pain relief that was sustained for at least the typical duration of an episode of BTCP (summed pain intensity difference at 30 and 60 minutes) (Portenoy et al, 2010; Davies et al, 2011; Fallon et al, 2011). In addition, FPNS yielded significantly higher patient satisfaction scores than those treated with placebo (p
