Relationship of effective titrated dose of fentanyl pectin nasal spray to background opioid dose in breakthrough pain in cancer.

Abstract

e19591 Background: Randomized controlled trials have confirmed fentanyl pectin nasal spray (FPNS) provides rapid analgesic onset and consistent efficacy that are highly acceptable to patients for the treatment of breakthrough pain in cancer (BTPc). This is an analysis of the relationship between around-the-clock (ATC) background opioid dose and the effective titrated dose of FPNS, in addition to FPNS dose consistency, in a long-term trial. Methods: Patients who experienced 1–4 BTPc episodes/day while taking ≥60 mg/day oral morphine (or equivalent) for cancer-related pain entered the 16-week, open-label trial directly or after participation in a previous study. During the titration phase, an effective dose (FPNS 100–800 μg) was identified as the dose that treated two consecutive episodes of BTPc without unacceptable adverse events. Results: The intent-to-treat population (N = 403) experienced an average of 2.81 BTPc episodes/day (range, 1–10 episodes/day), which were predominantly moderate to severe in intensity (88 [21.8%] and 312 [77.4%], respectively). Morphine sulfate and fentanyl were the most commonly used ATC medications, with one-third of patients receiving each, respectively. Given the available FPNS doses, the initial titration phase required a minimal number of titration steps (mean, 2.7), and more than 90% of patients required no increase in their initial titrated dose of FPNS at 16 weeks. The effective titrated dose of FPNS did not correlate with the calculated daily morphine equivalent dose. Furthermore, no correlation was found between the oral morphine-only ATC dose and the effective FPNS dose. Conclusions: FPNS is a convenient and consistently effective option for the management of BTPc. No correlation was demonstrated between a patient’s ATC opioid dose and the effective titrated dose of FPNS in this analysis, thus highlighting the importance of an initial titration. However, titration can be achieved in a minimal number of steps, often without the need to further increase the dose during long-term treatment.