(772): Patient preference for fentanyl buccal tablet (FBT) in the management of breakthrough pain: Open-label evaluation in opioid-tolerant patients with chronic noncancer pain

Abstract

Rapid-onset opioids are needed to address the gap between time to peak intensity (∼10 min) of breakthrough pain (BTP) and onset of analgesia provided by short-acting opioids (30-60 min). Fentanyl buccal tablet (FBT) is designed to provide rapid-onset of analgesia by enhancing transbuccal absorption of fentanyl. To evaluate patients’ preference for FBT versus previous BTP therapy, opioid-tolerant patients with chronic noncancer pain completed a global medication performance assessment (GMPA, measured monthly) and medication preference questionnaire (completed after 1 and 12 months, and/or at last visit) in an 18-month open-label study. Results of an interim analysis among patients who received at least 6 months’ treatment are presented. Enrolling patients were either treatment-naı̈ve or previously treated with FBT in one of two double-blind studies. Naı̈ve patients identified an effective FBT dose in a titration phase; previously treated patients continued on their established effective doses. On entering the study, all patients had 1-4 BTP episodes/day while using fixed-dose opioid therapy for persistent pain. Primary chronic pain conditions included low back pain, headache, osteoarthritis, traumatic injury, and complex regional pain syndrome. Previous supplemental opioids used to treat BTP included oxycodone, hydrocodone, fentanyl, morphine, and hydromorphone. After one month, the majority of patients (91%, 435/477) reported they preferred FBT to their previous supplemental opioids according to the questionnaire. Most patients reported that FBT provided a more rapid onset of analgesia (95%, 452/477), was easier to administer (71%, 341/477), and was more convenient to use (68%, 323/477) than their previous supplemental opioids. Most patients rated FBT as “excellent” or “good” for onset of action (94%), ease of administration (81%), and convenience (79%). At 6 months, 93% (272/292) of patients rated FBT as “good,” “very good,” or “excellent” on the GMPA. In sum, most patients preferred FBT to the opioids previously used to treat their BTP. Rapid-onset opioids are needed to address the gap between time to peak intensity (∼10 min) of breakthrough pain (BTP) and onset of analgesia provided by short-acting opioids (30-60 min). Fentanyl buccal tablet (FBT) is designed to provide rapid-onset of analgesia by enhancing transbuccal absorption of fentanyl. To evaluate patients’ preference for FBT versus previous BTP therapy, opioid-tolerant patients with chronic noncancer pain completed a global medication performance assessment (GMPA, measured monthly) and medication preference questionnaire (completed after 1 and 12 months, and/or at last visit) in an 18-month open-label study. Results of an interim analysis among patients who received at least 6 months’ treatment are presented. Enrolling patients were either treatment-naı̈ve or previously treated with FBT in one of two double-blind studies. Naı̈ve patients identified an effective FBT dose in a titration phase; previously treated patients continued on their established effective doses. On entering the study, all patients had 1-4 BTP episodes/day while using fixed-dose opioid therapy for persistent pain. Primary chronic pain conditions included low back pain, headache, osteoarthritis, traumatic injury, and complex regional pain syndrome. Previous supplemental opioids used to treat BTP included oxycodone, hydrocodone, fentanyl, morphine, and hydromorphone. After one month, the majority of patients (91%, 435/477) reported they preferred FBT to their previous supplemental opioids according to the questionnaire. Most patients reported that FBT provided a more rapid onset of analgesia (95%, 452/477), was easier to administer (71%, 341/477), and was more convenient to use (68%, 323/477) than their previous supplemental opioids. Most patients rated FBT as “excellent” or “good” for onset of action (94%), ease of administration (81%), and convenience (79%). At 6 months, 93% (272/292) of patients rated FBT as “good,” “very good,” or “excellent” on the GMPA. In sum, most patients preferred FBT to the opioids previously used to treat their BTP.