Majority of Patients Satisfied with Fentanyl Sublingual Spray for Breakthrough Cancer Pain

HONOLULU, HI—Compared with previous medications for breakthrough cancer pain, use of fentanyl sublingual spray significantly improved patient satisfaction, a study presented at the American Pain Society's 31st Annual Scientific Meeting has concluded.

Lowell W. Reynolds, MD, Loma Linda University, Loma Linda, CA, and colleagues examined satisfaction with fentanyl sublingual spray in a randomized, placebo-controlled study of 130 patients during a 26-day open-label titration phase and 96 patients who received double-blind treatment for 26 days. Patients who were opioid-tolerant and had 1–4 episodes of breakthrough cancer pain per day were included in the study.

In the titration phase, a 100–1600mcg fentanyl sublingual spray dose was established that provided effective analgesia for 2 consecutive episodes of breakthrough cancer pain. During the double-blind phase, patients received 7 units of study medication and 3 units of placebo.

The Treatment Satisfaction Questionnaire for Medication was used to assess satisfaction with previous medication for breakthrough cancer pain at baseline and satisfaction with fentanyl sublingual spray at the end of titration. During double-blind treatment, global evaluation of study medication was performed at 30 and 60 minutes postdose.

All Treatment Satisfaction Questionnaire for Medication domains increased from baseline to end of titration. The investigators found the greatest improvement to be effectiveness (mean [SE]: 48.8 [1.6] to 75.2 [1.4]) and global satisfaction (55.1 [1.9] to 75.4 [1.7]). Satisfaction with symptom relief improved to 89.5%, from 41.4% with previous medication for breakthrough cancer pain. Compared with placebo, fentanyl sublingual spray significantly improved mean global evaluation scores at 30 and 60 minutes (P<0.0001).

During the titration phase, 78 patients (60%) reported at least 1 adverse event (AE), as did 47 (48%) patients during the double-blind treatment. Common AEs during the titration phase were nausea (13.1%) and somnolence (8.5%) and, during double-blind treatment, nausea (7.1%), peripheral edema (5.1%), and hyperhidrosis (5.1%). The majority of the AEs (88%) were mild or moderate in severity.