HONOLULU, HI—Patientswith chronic, noncancer-related pain who received fentanyl buccal tablet had consistent short-term efficacy acrossclinically meaningful analgesia measures, according to results of a study presentedat the American Pain Society’s 31st Annual Scientific Meeting.
Arvind Narayana, MD, MBA, of Teva Pharmaceuticals, Frazer, PA, andcolleagues assessed the consistency of analgesia outcomes in a combinedanalysis of two similarly designed, randomized, double-blind,placebo-controlled studies in patients with chronic neuropathic or low backpain who received fentanyl buccal tablet. Previously, this formulation wasshown to be effective for the treatment of breakthrough pain in patients withnoncancer-related pain receiving long-term opioid therapy.
Patients received a dose-titration kit containing100-, 200-, 400-, 600- and 800mcg doses of fentanyl buccal tablet to be used inidentifying a dose that controlled their breakthrough pain. A successful dosewas identified as that which the patient reported adequate pain relief for atleast 2 of 3 episodes of breakthrough pain without requiring supplementalmedication and without experiencing unacceptable adverse events (AEs).
After open-label titration to an effective doseof fentanyl buccal tablet, patients were randomized to one of threedouble-blind treatment sequences to treat nine consecutive breakthrough painepisodes, six with fentanyl buccal tablet and three with placebo. Of 208patients enrolled, 148 (71%) were evaluable for efficacy and experienced 1,265episodes of breakthrough pain. Measurement of analgesic efficacy was initiatedat 5 minutes following each episode and continued through 120 minutes.
Patients who received fentanyl buccal tablet hada consistently greater effect beginning at 10 minutes, as reflected in theproportion of episodes with a ≥2-point improvement in pain intensity (14-75%)compared with placebo (9–40%). Significant between-group differences in favorof fentanyl buccal tablet were sustained through 120 minutes post-treatment.
A consistently greater effect was observed in theproportion of breakthrough pain episodes with ≥33% or ≥50% improvement in painintensity from baseline in the patients given fentanyl buccal tablet comparedwith placebo beginning at 10 minutes and continuing to 120 minutes.
Similar results were noted for the proportion ofepisodes with a pain relief score of ≥2 with fentanyl buccal tablet vs. placebobeginning at 15 minutes. Between-group differences in favor of fentanyl buccaltablet were sustained through 120 minutes post-treatment, the investigatorsnoted. In addition, evaluation of pain intensity and pain relief measures at 30minutes after the start of breakthrough pain showed that the responses tofentanyl buccal tablets were approximately 2.5 to 3 times higher than those toplacebo across all evaluations.
Fentanyl buccal tablet was generally welltolerated; 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%). Oneaccidental overdose occurred that was considered to be possibly related totreatment: a patient took four 600mcg fentanyl buccal tablets simultaneouslywithout explanation and was revived with oxygen and admitted to the hospital;he recovered fully.