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Multi-study analysis of patients' preference for fentanyl buccal tablet (FBT) in the management of breakthrough pain
Donald R. Taylor, MD1, John Messina, PharmD2, Fang Xie, PhD2, and Lynn R. Webster, MD, FACPM, FASAM3. (1) Comprehensive Pain Care, P.C, 840 Church Street, Suite B, Marietta, GA 30060, (2) Cephalon, Inc., 41 Moores Road, Frazer, PA 19356, (3) Lifetree Clinical Research and Pain Clinic, 3838 South 7th East, Suite 200, Salt Lake City, UT 84106
Fentanyl buccal tablet (FBT) has been recently approved for the management of breakthrough pain (BTP) in opioid-tolerant patients with controlled, chronic cancer pain. The efficacy and tolerability of FBT in managing BTP have also been studied in opioid-tolerant patients with chronic noncancer pain. We present an analysis across three such studies, in which patients completed a medication preference questionnaire at 1 month in an open-label study, or upon completing one of two randomized, double-blind studies. On entering the studies, opioid-tolerant patients with chronic noncancer pain were experiencing 1-4 BTP episodes/day while using fixed-dose opioids for the treatment of persistent pain. Their underlying chronic pain conditions included low back pain, neuropathic pain, headache, osteoarthritis, and traumatic injury. Medications used for BTP at study entry included oxycodone, hydrocodone, oral transmucosal fentanyl citrate (OTFC), and morphine. A total of 548 patients completed the medication preference questionnaire, and a strong majority (89%) preferred FBT to their previous supplemental opioids. In a subset of patients (n=41) who had previously used OTFC (the only other FDA-approved treatment for BTP), 80% preferred FBT. Patients reported that FBT provided a more rapid onset of analgesia (94%, all patients; 85%, OTFC subgroup), was easier to administer (70%, all; 83%, OTFC), and more convenient to use (68%, all; 85%, OTFC) than their previous supplemental opioids. Patients rated FBT as “excellent” or “good” regarding onset of action (92%, all patients; 85%, OTFC subgroup), ease of administration (83%, all; 88%, OTFC), and convenience of use (80%, all; 93%, OTFC). In summary, a combined analysis of three studies of patients with BTP and persistent noncancer pain showed that a clear majority of patients preferred FBT to their previous BTP medication; results were similar in a subgroup of patients who had previously used OTFC to treat their BTP.
