The efficacy, tolerability, and speed of onset of fentanyl pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain (BTCP): A multicenter, placebo-controlled, double-blind, two-phase crossover study

Abstract

9535 Background: Breakthrough cancer pain (BTCP) affects up to 95% of patients with cancer pain but oral fentanyl formulations do not consistently match the typical time course of BTCP, which is rapid in onset and lasts for 30–60 min. To tailor fentanyl delivery for the treatment of BTCP, a new nasal formulation of fentanyl (fentanyl pectin nasal spray [FPNS]) has been developed to provide both rapid and controlled nasal delivery of fentanyl. Methods: A randomised, placebo-controlled, double-blind (DB) study assessing the efficacy and tolerability of FPNS was conducted in 114 cancer patients experiencing 1–4 BTCP episodes/day while taking ≥60 mg/day of oral morphine (or equivalent) for cancer pain. Patients who completed a titration phase (N=83) continued to a DB phase where 10 episodes of BTCP were treated with the effective dose identified during titration (7) or placebo (3). Pain intensity (PI) was measured using an 11-point categorical scale and pain relief (PR) using a 5-point scale, both PI and PR were measured at 5, 10, 15, 45 and 60 min post-dose. The primary endpoint was the Summed Pain Intensity Difference at 30 min (SPID30min). Secondary efficacy endpoints included Pain Intensity Difference (PID) from baseline, PI and PR. Safety was assessed by adverse events (AEs) and both objective and subjective nasal assessments. Results: Compared with placebo, FPNS significantly improved mean SPID30min scores (P<0.0001) and significantly improved SPID scores as early as 10 min (P<0.05) and up to 60 min (P<0.0001). Significant differences in favour of FPNS were found in PI as early as 5 min (P<0.05). Similar benefits were also seen with PID, with a trend at 5 min (P=0.07) that was significant from 10 min onward (P<0.01). PR was significant from 10 min (P<0.001) and at all time points to 60 min (P<0.001). Only 5.3% of patients withdrew from titration due to AEs; no significant nasal effects were reported. Conclusions: FPNS provided rapid and effective analgesia in BTCP and was generally safe and well tolerated. [Table: see text]