Consistent efficacy with fentanyl buccal tablet in the treatment of breakthrough pain in patients receiving maintenance opioid therapy for chronic, persistent noncancer-related pain

Abstract

Fentanyl buccal tablet has been shown to be effective for the treatment of breakthrough pain (BTP) in patients with noncancer-related pain receiving long-term opioid therapy. In a combined analysis of 2 similarly designed, randomized, double-blind, placebo-controlled studies, the consistency of analgesia outcomes with fentanyl buccal tablet was assessed in patients with chronic neuropathic or low back pain. Following open-label titration to an effective dose of fentanyl buccal tablet, patients were randomized to 1 of 3 double-blind treatment sequences to treat 9 consecutive BTP episodes (6 with fentanyl buccal tablet; 3 with placebo). Analgesic efficacy was measured beginning at 5 minutes post-episode and continuing through 120 minutes. Of the 208 patients enrolled, 148 were evaluable for efficacy and experienced 1265 BTP episodes. A consistently greater effect was noted beginning at 10 minutes with fentanyl buccal tablet, as reflected in the proportion of episodes with a ≥2-point improvement in pain intensity (14-75%) vs placebo (9-40%). Similar findings beginning at 15 minutes were observed for the proportion of episodes with pain relief score ≥2 with fentanyl buccal tablet (10-73%) vs placebo (7-36%). Significant between-group differences in favor of fentanyl buccal tablet were sustained through 120 minutes post-treatment (last time point evaluated). Other measures of clinically relevant analgesia, including meaningful pain relief and ≥33% improvements in pain intensity, showed similar results to the measures above. Fentanyl buccal tablet was generally well tolerated; the most frequently reported adverse events in either study were nausea, dizziness, somnolence, dysgeusia, vomiting, and dry mouth. There was 1 related serious adverse event of accidental overdose in the 2 studies. Results of this analysis support the consistent short-term efficacy of fentanyl buccal tablet across clinically meaningful analgesia measures in patients with chronic, noncancer-related pain receiving long-term opioid therapy. Sponsored by Cephalon, Inc.