Fentanyl Buccal Tablet Consistently Treats Chronic, Persistent Noncancer-Related Pain

HONOLULU, HI—Patients with chronic, noncancer-related pain who received fentanyl buccal tablet had consistent short-term efficacy across clinically meaningful analgesia measures, according to results of a study presented at the American Pain Society's 31st Annual Scientific Meeting.

Arvind Narayana, MD, MBA, of Teva Pharmaceuticals, Frazer, PA, and colleagues assessed the consistency of analgesia outcomes in a combined analysis of two similarly designed, randomized, double-blind, placebo-controlled studies in patients with chronic neuropathic or low back pain who received fentanyl buccal tablet. Previously, this formulation was shown to be effective for the treatment of breakthrough pain in patients with noncancer-related pain receiving long-term opioid therapy.

Patients received a dose-titration kit containing 100-, 200-, 400-, 600- and 800mcg doses of fentanyl buccal tablet to be used in identifying a dose that controlled their breakthrough pain. A successful dose was identified as that which the patient reported adequate pain relief for at least 2 of 3 episodes of breakthrough pain without requiring supplemental medication and without experiencing unacceptable adverse events (AEs).

After open-label titration to an effective dose of fentanyl buccal tablet, patients were randomized to one of three double-blind treatment sequences to treat nine consecutive breakthrough pain episodes, six with fentanyl buccal tablet and three with placebo. Of 208 patients enrolled, 148 (71%) were evaluable for efficacy and experienced 1,265 episodes of breakthrough pain. Measurement of analgesic efficacy was initiated at 5 minutes following each episode and continued through 120 minutes.

Patients who received fentanyl buccal tablet had a consistently greater effect beginning at 10 minutes, as reflected in the proportion of episodes with a ≥2-point improvement in pain intensity (14-75%) compared with placebo (9–40%). Significant between-group differences in favor of fentanyl buccal tablet were sustained through 120 minutes post-treatment.

A consistently greater effect was observed in the proportion of breakthrough pain episodes with ≥33% or ≥50% improvement in pain intensity from baseline in the patients given fentanyl buccal tablet compared with placebo beginning at 10 minutes and continuing to 120 minutes.

Similar results were noted for the proportion of episodes with a pain relief score of ≥2 with fentanyl buccal tablet vs. placebo beginning at 15 minutes. Between-group differences in favor of fentanyl buccal tablet were sustained through 120 minutes post-treatment, the investigators noted. In addition, evaluation of pain intensity and pain relief measures at 30 minutes after the start of breakthrough pain showed that the responses to fentanyl buccal tablets were approximately 2.5 to 3 times higher than those to placebo across all evaluations.

Fentanyl buccal tablet was generally well tolerated; the most frequently reported adverse events in study 1 and study 2, respectively, were nausea (13%, 19%), dizziness (13%, 13%), somnolence (10%, 9%), dysgeusia (3%, 8%), vomiting (5%, 6%), and dry mouth (2%, 5%). One accidental overdose occurred that was considered to be possibly related to treatment: a patient took four 600mcg fentanyl buccal tablets simultaneously without explanation and was revived with oxygen and admitted to the hospital; he recovered fully.