HONOLULU, HI—Compared with previous medications for breakthroughcancer pain, use of fentanyl sublingual spray significantly improved patientsatisfaction, a study presented at the American Pain Society’s 31stAnnual Scientific Meeting has concluded.

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

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


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The TreatmentSatisfaction Questionnaire for Medication was used to assess satisfaction withprevious medication for breakthrough cancer pain at baseline and satisfactionwith fentanyl sublingual spray at the end of titration. During double-blindtreatment, global evaluation of study medication was performed at 30 and 60minutes postdose.

All TreatmentSatisfaction Questionnaire for Medication domains increased from baseline toend 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% withprevious medication for breakthrough cancer pain. Compared with placebo,fentanyl sublingual spray significantly improved mean global evaluation scoresat 30 and 60 minutes (P<0.0001).

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