Fentanyl sublingual spray for breakthrough cancer pain in patients receiving transdermal fentanyl.

Abstract

175 Background: Sublingual fentanyl spray is indicated for the treatment of breakthrough cancer pain (BTCP) in opioid-tolerant patients receiving around-the-clock (ATC) opioids. This post hoc analysis characterized patients receiving ATC transdermal fentanyl patch (TFP) who also received fentanyl sublingual spray for BTCP during a phase 3, randomized, placebo-controlled trial. Methods: Opioid-tolerant adults (n=130) receiving ATC opioids for baseline pain, with 1 to 4 episodes/day of BTCP, were enrolled in a 26-day open-label titration period and received fentanyl sublingual spray. Patients who successfully titrated to a stable, effective dose (100-1,600 mcg) of fentanyl sublingual spray entered a 26-day double-blind period. Patient satisfaction was assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM). Adverse events (AEs) were monitored throughout the study. Results: Of the 50 patients (mean age, 50 years) who were on ATC TFP at baseline, most were male (58%) and white (90%) with a mean of 2.4 BTCP episodes/day. The most common types of cancer were reproductive (22%), head and neck (14%), and lung (8%). The percentage of patients in each cancer stage was 0/I (14%), II (10%), III/IV (48%), or unknown/not applicable (28%). Thirty-two of 50 patients (64%) achieved an effective dose of sublingual fentanyl spray and entered the double-blind period. In the 32 patients, the mean baseline TFP dose at the beginning of double-blind period was 81.4 mcg. The mean daily number of BTCP episodes during the 26-day double-blind period was 2.3 (range, 1-5). Mean TSQM scores at baseline and end of the titration period, respectively, were as follows: effectiveness, 49.0 vs 78.3; side effects, 65.0 vs 94.4; convenience, 61.6 vs 73.8; and global satisfaction, 49.3 vs 72.8. The effective dose of fentanyl sublingual spray only moderately correlated with the mean TFP dose (r=0.4; P=0.03). During the double-blind period, 19 of 32 patients (59%) reported AEs; the most common AEs were nausea (9%) and peripheral edema (9%). No opioid overdoses were reported. Conclusions: The findings support that fentanyl sublingual spray relieves BTCP and is well tolerated in most patients receiving ATC transdermal fentanyl. Clinical trial information: NCT00538850.