Impact of fentanyl buccal tablet on both patient and clinician ratings of patient function

We evaluated the effects of Fentanyl Buccal Tablet (FBT) over a 12-week treatment period, with secondary assessments of patient function. Opioid-tolerant adults with chronic non-cancer pain and BTP (1-4 episodes/day) were titrated to a single successful FBT dose (100-800 mcg providing adequate analgesia without unacceptable AEs) and then entered a 4-week open-label period (at the successful dose) followed by double-blind, randomized treatment for 9 BTP episodes (6 FBT, 3 placebo). The open-label/double-blind sequence was repeated twice. Patient function was assessed using the Brief Pain Inventory-Short Form (BPI-SF) and three questionnaires based on the functional component of the BPI-SF. Patients and clinicians rated the level of change on items related to functioning since starting the study as a global assessment after week 12 or early withdrawal (endpoint). Evaluations included the Goal Attainment Scale (GAS; patients rated change in 3 of 7 functional factors they selected a priori as important), Patient Assessment of Function questionnaire (PAF; 7 questions rated on a 7-point scale, very much worsened to very much improved), and Clinician Assessment of Patient Function questionnaire (CAPF; 5 questions rated on a 7-point scale, very much worsened to very much improved). BPI-SF: evaluations showed little change from baseline to endpoint. GAS: 44/59 (75%) patients reported an improvement in their general activity, with similar results for other functional factors, e.g., mood (82%), sleep (63%). PAF: >50% of patients reported some improvement in 5/7 areas of functioning, including a majority who reported an improvement in the ability to perform at work (77%), participate in social events (74%), and enjoy life (76%). CAPF: Clinicians reported some improvement in each area of functioning for >60% of patients. AEs were generally typical of opioids. In conclusion, FBT had consistently positive effects on function in opioid-tolerant patients with BTP. Sponsored by Cephalon, Inc.