Long-term safety and analgesic efficacy of buprenorphine buccal film in patients with moderate-to-severe chronic pain requiring around-the-clock opioids
Martin Hale,1 Veronica Urdaneta,2 M Todd Kirby,3 Qinfang Xiang,4 Richard Rauck5 1Gold Coast Research, LLC, Plantation, FL, USA; 2Pharmacovigilance and Risk Management, 3Clinical Development, 4Biometrics, Endo Pharmaceuticals Inc., Malvern, PA, USA; 5Carolinas Pain Institute, Wake Forest Baptist Heal...
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doaj-13c503ddf9d74bb3980a1d85538171652020-11-25T01:26:10ZengDove Medical PressJournal of Pain Research1178-70902017-01-01Volume 1023324031010Long-term safety and analgesic efficacy of buprenorphine buccal film in patients with moderate-to-severe chronic pain requiring around-the-clock opioidsHale MUrdaneta VKirby MTXiang QRauck RMartin Hale,1 Veronica Urdaneta,2 M Todd Kirby,3 Qinfang Xiang,4 Richard Rauck5 1Gold Coast Research, LLC, Plantation, FL, USA; 2Pharmacovigilance and Risk Management, 3Clinical Development, 4Biometrics, Endo Pharmaceuticals Inc., Malvern, PA, USA; 5Carolinas Pain Institute, Wake Forest Baptist Health, Winston Salem, NC, USA Background: This open-label, single-arm study was conducted to evaluate the long-term safety and efficacy of a novel buprenorphine formulation, buprenorphine buccal film, in the treatment of moderate-to-severe chronic pain requiring around-the-clock opioids.Methods: The primary purpose of this study was to evaluate the long-term safety and tolerability of buprenorphine buccal film. Five hundred and six patients who completed previous studies with buprenorphine buccal film (n=445; rollover patients) or were recruited de novo for this study (n=61) were enrolled in this study. All patients underwent a dose titration period of ≤6 weeks, during which doses of buprenorphine buccal film were adjusted to a maximum 900 µg every 12 hours, depending on tolerability and the need for rescue medication. An optimal dose was defined as the dose that the patient found satisfactory for both pain relief and tolerability, without the need for rescue medication or with ≤2 tablets of rescue medication per day. Once the optimal dose was reached, treatment was continued for ≤48 weeks. Pain intensity was measured throughout the study using a 0–10 numerical rating scale.Results: Of 435 patients achieving an optimal dose of buprenorphine buccal film who commenced long-term treatment, 158 (36.3%) completed 48 weeks of treatment. Treatment-related adverse events occurred in 116 patients (22.9%) during the titration phase and 61 patients (14.0%) during the long-term treatment phase, and adverse events leading to discontinuation of treatment occurred in 14 (2.8%) and 14 (3.2%) patients, respectively. The most common adverse events were those typically associated with opioids, such as nausea, constipation, and headache. In both rollover and de novo patients, pain intensity scores remained constant at approximately 3–4 during long-term treatment, and the dose of buprenorphine buccal film remained unchanged in 86.2% of patients.Conclusion: In appropriate patients, buprenorphine buccal film demonstrated tolerability and efficacy in the long-term management of chronic pain.Keywords: buccal drug administration, buprenorphine, chronic pain management, long-term treatment, opioid analgesicshttps://www.dovepress.com/long-term-safety-and-analgesic-efficacy-of-buprenorphine-buccal-film-i-peer-reviewed-article-JPRBuccal drug administrationbuprenorphinechronic pain managementlong-term treatmentopioid analgesics |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Hale M Urdaneta V Kirby MT Xiang Q Rauck R |
spellingShingle |
Hale M Urdaneta V Kirby MT Xiang Q Rauck R Long-term safety and analgesic efficacy of buprenorphine buccal film in patients with moderate-to-severe chronic pain requiring around-the-clock opioids Journal of Pain Research Buccal drug administration buprenorphine chronic pain management long-term treatment opioid analgesics |
author_facet |
Hale M Urdaneta V Kirby MT Xiang Q Rauck R |
author_sort |
Hale M |
title |
Long-term safety and analgesic efficacy of buprenorphine buccal film in patients with moderate-to-severe chronic pain requiring around-the-clock opioids |
title_short |
Long-term safety and analgesic efficacy of buprenorphine buccal film in patients with moderate-to-severe chronic pain requiring around-the-clock opioids |
title_full |
Long-term safety and analgesic efficacy of buprenorphine buccal film in patients with moderate-to-severe chronic pain requiring around-the-clock opioids |
title_fullStr |
Long-term safety and analgesic efficacy of buprenorphine buccal film in patients with moderate-to-severe chronic pain requiring around-the-clock opioids |
title_full_unstemmed |
Long-term safety and analgesic efficacy of buprenorphine buccal film in patients with moderate-to-severe chronic pain requiring around-the-clock opioids |
title_sort |
long-term safety and analgesic efficacy of buprenorphine buccal film in patients with moderate-to-severe chronic pain requiring around-the-clock opioids |
publisher |
Dove Medical Press |
series |
Journal of Pain Research |
issn |
1178-7090 |
publishDate |
2017-01-01 |
description |
Martin Hale,1 Veronica Urdaneta,2 M Todd Kirby,3 Qinfang Xiang,4 Richard Rauck5 1Gold Coast Research, LLC, Plantation, FL, USA; 2Pharmacovigilance and Risk Management, 3Clinical Development, 4Biometrics, Endo Pharmaceuticals Inc., Malvern, PA, USA; 5Carolinas Pain Institute, Wake Forest Baptist Health, Winston Salem, NC, USA Background: This open-label, single-arm study was conducted to evaluate the long-term safety and efficacy of a novel buprenorphine formulation, buprenorphine buccal film, in the treatment of moderate-to-severe chronic pain requiring around-the-clock opioids.Methods: The primary purpose of this study was to evaluate the long-term safety and tolerability of buprenorphine buccal film. Five hundred and six patients who completed previous studies with buprenorphine buccal film (n=445; rollover patients) or were recruited de novo for this study (n=61) were enrolled in this study. All patients underwent a dose titration period of ≤6 weeks, during which doses of buprenorphine buccal film were adjusted to a maximum 900 µg every 12 hours, depending on tolerability and the need for rescue medication. An optimal dose was defined as the dose that the patient found satisfactory for both pain relief and tolerability, without the need for rescue medication or with ≤2 tablets of rescue medication per day. Once the optimal dose was reached, treatment was continued for ≤48 weeks. Pain intensity was measured throughout the study using a 0–10 numerical rating scale.Results: Of 435 patients achieving an optimal dose of buprenorphine buccal film who commenced long-term treatment, 158 (36.3%) completed 48 weeks of treatment. Treatment-related adverse events occurred in 116 patients (22.9%) during the titration phase and 61 patients (14.0%) during the long-term treatment phase, and adverse events leading to discontinuation of treatment occurred in 14 (2.8%) and 14 (3.2%) patients, respectively. The most common adverse events were those typically associated with opioids, such as nausea, constipation, and headache. In both rollover and de novo patients, pain intensity scores remained constant at approximately 3–4 during long-term treatment, and the dose of buprenorphine buccal film remained unchanged in 86.2% of patients.Conclusion: In appropriate patients, buprenorphine buccal film demonstrated tolerability and efficacy in the long-term management of chronic pain.Keywords: buccal drug administration, buprenorphine, chronic pain management, long-term treatment, opioid analgesics |
topic |
Buccal drug administration buprenorphine chronic pain management long-term treatment opioid analgesics |
url |
https://www.dovepress.com/long-term-safety-and-analgesic-efficacy-of-buprenorphine-buccal-film-i-peer-reviewed-article-JPR |
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