Functioning/satisfaction with fentanyl buccal tablet compared to traditional short-acting opioids for the management of breakthrough pain in opioid-tolerant patients with chronic pain

Abstract

There are limited data directly comparing different treatments for breakthrough pain (BTP). After obtaining IRB approval and informed written consent, opioid-tolerant adults with BTP who completed a randomized, double-blind, crossover study were re-randomized to fentanyl buccal tablet (FBT) or any traditional short-acting opioid (SAO) for 12 weeks of open-label treatment. Patients/clinicians completed the following functionality/satisfaction assessments: Patient Assessment of Function (PAF), Clinician Assessment of Patient Function (CAPF), Patient Global Impression of Change (PGIC), and Clinical Global Impression of Change (CGIC). All assessments were rated on a 7-point scale, from very much worsened to very much improved. 130 patients received treatment (65, FBT; 65, SAO). For the PAF, more patients receiving FBT than SAO reported improvement in 11 of 12 areas of functioning (P<0.05 for 7 areas of functioning), including improvement in enjoyment of life (72% vs 43%; P=0.001 for the distribution of responses). For the CAPF, clinicians reported that more patients improved in all 12 areas of functioning (P<0.05 for 6 areas of functioning) with FBT than SAO, including improvement in enjoyment of life (68% vs 38%; P<0.001). Responses to the PGIC and CGIC also favored FBT vs SAO (PGIC: mean [SD] 1.5 [1.02] vs 0.9 [1.09]; CGIC: 1.4 [1.01] vs 0.7 [1.05]; both P<0.001). Adverse events were generally similar between treatments and typical of opioids. In conclusion, following 12 weeks of open-label treatment, patients and clinicians reported consistently better efficacy, including functional improvement, with FBT than with traditional SAOs in opioid-tolerant patients with BTP. Supported by Cephalon, Inc. There are limited data directly comparing different treatments for breakthrough pain (BTP). After obtaining IRB approval and informed written consent, opioid-tolerant adults with BTP who completed a randomized, double-blind, crossover study were re-randomized to fentanyl buccal tablet (FBT) or any traditional short-acting opioid (SAO) for 12 weeks of open-label treatment. Patients/clinicians completed the following functionality/satisfaction assessments: Patient Assessment of Function (PAF), Clinician Assessment of Patient Function (CAPF), Patient Global Impression of Change (PGIC), and Clinical Global Impression of Change (CGIC). All assessments were rated on a 7-point scale, from very much worsened to very much improved. 130 patients received treatment (65, FBT; 65, SAO). For the PAF, more patients receiving FBT than SAO reported improvement in 11 of 12 areas of functioning (P<0.05 for 7 areas of functioning), including improvement in enjoyment of life (72% vs 43%; P=0.001 for the distribution of responses). For the CAPF, clinicians reported that more patients improved in all 12 areas of functioning (P<0.05 for 6 areas of functioning) with FBT than SAO, including improvement in enjoyment of life (68% vs 38%; P<0.001). Responses to the PGIC and CGIC also favored FBT vs SAO (PGIC: mean [SD] 1.5 [1.02] vs 0.9 [1.09]; CGIC: 1.4 [1.01] vs 0.7 [1.05]; both P<0.001). Adverse events were generally similar between treatments and typical of opioids. In conclusion, following 12 weeks of open-label treatment, patients and clinicians reported consistently better efficacy, including functional improvement, with FBT than with traditional SAOs in opioid-tolerant patients with BTP. Supported by Cephalon, Inc.