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1

Hale, Martin, Joseph Gimbel, and Richard Rauck. "Buprenorphine buccal film for chronic pain management." Pain Management 10, no. 4 (2020): 213–23. http://dx.doi.org/10.2217/pmt-2020-0013.

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Buprenorphine is a Schedule III opioid with unique pharmacodynamic and pharmacokinetic properties that contribute to effective analgesia and fewer safety risks than other opioids. This review article focuses on the buccal film formulation, which is preferable to other buprenorphine formulations on the basis of bioavailability, safety and efficacy. The clinical studies reviewed here confirm that buprenorphine buccal film offers effective and continuous pain relief that is generally well tolerated, with no cases of respiratory depression reported in any of the studies. On the basis of these clin
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2

Jackson, Leanne K., Ivy O. Poon, Mary A. Garcia, Syed Imam, and Ursula K. Braun. "Buprenorphine Use for Analgesia in Palliative Care." Pharmacy 12, no. 3 (2024): 78. http://dx.doi.org/10.3390/pharmacy12030078.

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Buprenorphine is a semi-synthetic long-acting partial µ-opioid receptor (MOR) agonist that can be used for chronic pain as a sublingual tablet, transdermal patch (Butrans®), or a buccal film (Belbuca®). Buprenorphine’s unique high receptor binding affinity and slow dissociation at the MOR allow for effective analgesia while offering less adverse effects compared to a full agonist opioid, in particular, less concern for respiratory depression and constipation. It is underused in chronic pain and palliative care due to misconceptions and stigma from its use in opioid use disorder (OUD). This cas
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3

Zimmerman, Amanda. "Conversion of CII Opioid Medications to Buprenorphine in the Chronic Pain Population - Insights and Clinical Pearls." Journal of Opioid Management 20, no. 4 (2024): B11. http://dx.doi.org/10.5055/bupe.24.rpj.1060.

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Background: There is a great deal of confusion associated with conversion from CII opioid to buprenorphine products. The data presented supports that patients can be converted from high dose opioid medication to buprenorphine products safely and effectively. This presentation will provide a road map to help guide practitioners who are interested in applying this to their clinical practice. Purpose/hypothesis: The purpose of the research was not only to discover if conversion to a partial agonist CIII medication from full agonist CII medications would be achieveable without sacrificing analgesi
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4

Soyka, Michael. "Buprenorphine–naloxone buccal soluble film for the treatment of opioid dependence: current update." Expert Opinion on Drug Delivery 12, no. 2 (2014): 339–47. http://dx.doi.org/10.1517/17425247.2014.953479.

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5

Webster, MD, Lynn, Jacqueline Cater, PhD, and Thomas Smith, MD. "Effects of buprenorphine buccal film and oral oxycodone on pupil diameter in a respiratory study." Journal of Opioid Management 18, no. 2 (2022): 181–90. http://dx.doi.org/10.5055/jom.2022.0708.

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Objective: Evaluate the pupillary-constricting effects following administration of buprenorphine buccal film (BBF) and immediate-release (IR) oxycodone.Design: A double-blind, double-dummy, six-treatment, six-period, placebo-controlled, randomized crossover study.Setting: Single-center, phase 1 exploratory pharmacodynamics.Participants: Healthy individuals who self-identify as recreational opioid users, confirmed via a naloxone challenge test on day 1.Interventions: Placebo: BBF 300, 600, and 900 mcg and IR oxycodone 30 and 60 mg.Main outcome measure: Minute ventilation (measured by the ventil
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6

Webster, Lynn, Jacqueline Cater, and Thomas Smith. "Risk Stratification of Respiratory Depression with Buprenorphine Buccal Film Versus Oxycodone: Phase 1 Trial Outcomes." Pain Management Nursing 23, no. 2 (2022): 247–48. http://dx.doi.org/10.1016/j.pmn.2022.02.065.

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7

Webster, Lynn, Jacqueline Cater, and Thomas Smith. "Buprenorphine Buccal Film Versus Oxycodone: Pupillometry and Respiratory Depression Effects in a Phase 1 Trial." Pain Management Nursing 23, no. 2 (2022): 248. http://dx.doi.org/10.1016/j.pmn.2022.02.066.

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8

Webster, Lynn, Jacqueline Cater, and Thomas Smith. "Buprenorphine Buccal Film Versus Oxycodone: Respiratory, Pharmacokinetic, and Pupillometry Outcomes from a Phase 1 Trial." Pain Management Nursing 23, no. 2 (2022): 247. http://dx.doi.org/10.1016/j.pmn.2022.02.064.

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9

Bai, Stephen A., Qinfang Xiang, and Andrew Finn. "Evaluation of the Pharmacokinetics of Single- and Multiple-dose Buprenorphine Buccal Film in Healthy Volunteers." Clinical Therapeutics 38, no. 2 (2016): 358–69. http://dx.doi.org/10.1016/j.clinthera.2015.12.016.

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10

Webster, MD, Lynn, and Richard L. Rauck, MD. "Atypical opioids and their effect on respiratory drive." Journal of Opioid Management 17, no. 7 (2021): 109–18. http://dx.doi.org/10.5055/jom.2021.0648.

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Opioids are an important tool in the treatment of pain, but opioid overdose has become a serious health issue. Most opioid-related deaths are caused by respiratory depression, and the risk of respiratory depression is compounded because of the risks of abuse and diversion, which makes the need for safer opioids even more urgent. However, the atypical opioids (buprenorphine, tramadol, and tapentadol), with mechanisms of action not purely driven by μ-opioid receptor agonism, may be safer than conventional opioids, eg, morphine, oxycodone, and fentanyl. The purpose of this narrative review is to
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11

Webster, Lynn, Jacqueline Cater, and Thomas Smith. "ID:15919 The Pharmacokinetics From a Phase 1 Placebo-Controlled Trial Comparing Buprenorphine Buccal Film and Oral Oxycodone." Neuromodulation: Technology at the Neural Interface 25, no. 4 (2022): S59—S60. http://dx.doi.org/10.1016/j.neurom.2022.02.201.

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12

Webster, Lynn, Jacqueline Cater, and Thomas Smith. "ID:15927 Buprenorphine Buccal Film Versus Oral Oxycodone: Effects on Pupillometry From a Phase 1 Placebo-Controlled Trial." Neuromodulation: Technology at the Neural Interface 25, no. 4 (2022): S61—S62. http://dx.doi.org/10.1016/j.neurom.2022.02.204.

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13

Webster, Lynn, Jacqueline Cater, and Thomas Smith. "ID:15929 Secondary Respiratory Outcomes of a Phase 1 Placebo-Controlled Trial: Buprenorphine Buccal Film Versus Oral Oxycodone." Neuromodulation: Technology at the Neural Interface 25, no. 4 (2022): S19—S20. http://dx.doi.org/10.1016/j.neurom.2022.02.151.

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14

Pergolizzi, Joseph, Robert B. Raffa, Charles Fleischer, Gianpietro Zampogna, and Robert Taylor. "Management of moderate to severe chronic low back pain with buprenorphine buccal film using novel bioerodible mucoadhesive technology." Journal of Pain Research Volume 9 (October 2016): 909–16. http://dx.doi.org/10.2147/jpr.s87952.

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15

Sullivan, James G., and Lynn Webster. "Novel Buccal Film Formulation of Buprenorphine-Naloxone for the Maintenance Treatment of Opioid Dependence: A 12-Week Conversion Study." Clinical Therapeutics 37, no. 5 (2015): 1064–75. http://dx.doi.org/10.1016/j.clinthera.2015.02.027.

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16

Webster, Lynn R., Erik Hansen, Jacqueline Cater, and Thomas Smith. "A Phase I Placebo-Controlled Trial Comparing the Effects of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride Administration on Respiratory Drive." Advances in Therapy 37, no. 11 (2020): 4685–96. http://dx.doi.org/10.1007/s12325-020-01481-0.

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17

Grbic, Dimitrije, Filip Stanicic, Djordje Vukojevic, and Vladimir Zah. "Safety Profile of Schedule III Buprenorphine and Schedule II Oral Opioids in Elderly with Chronic Low Back Pain: A Retrospective US Medicare Claims Analysis." Journal of Pain & Relief 13, no. 8 (2024): 1–24. https://doi.org/10.5281/zenodo.15235220.

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18

Hale, Martin, Veronica Urdaneta, Todd Kirby, Qinfang Xiang, and Richard Rauck. "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 Volume 10 (January 2017): 233–40. http://dx.doi.org/10.2147/jpr.s120170.

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19

Demchuk, M. B., T. A. Groshovyi, and N. V. Malanchyk. "Comparative study of assortment of medical films presented in the pharmaceutical markets of Ukraine, USA and Poland." Farmatsevtychnyi zhurnal, no. 1 (March 11, 2020): 12–19. http://dx.doi.org/10.32352/0367-3057.1.20.02.

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The development of medical films containing active substances immobilized on polymeric carriers become significantly popular in the world. Medical films belong to the application forms and designed for injection of active pharmaceutical ingredients through the skin, periodontal tissue, the mucous membrane of the mouth. There are transdermal therapeutic systems, including buccal, dental and oral films. Pharmaceutical manufacturers present a wide range of medicinal films containing various active ingredients on the world market.
 The purpose of our study was to conduct a comparison of the r
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20

Kazemi, Zahra, Seyed Mojtaba Taghizadeh, Seyed Tahmoures Keshavarz, and Farzad Lahootifard. "Effect of composition on mechanical and physicochemical properties of mucoadhesive buccal films containing buprenorphine hydrochloride: From design of experiments to optimal formulation." Journal of Drug Delivery Science and Technology 56 (April 2020): 101578. http://dx.doi.org/10.1016/j.jddst.2020.101578.

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21

Stanicic, Filip, Dimitrije Grbic, Djurdja Vukicevic, and Vladimir Zah. "Treatment characteristics of chronic low back pain patients treated with buprenorphine buccal film or transdermal patch." Pain Management, January 18, 2024. http://dx.doi.org/10.2217/pmt-2023-0124.

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Aims: Retrospective insurance claims analysis exploring treatment characteristics in chronic low back pain patients prescribed buprenorphine buccal film (Belbuca®) or transdermal patches. Patients and methods: The first buprenorphine prescription (buccal film or transdermal patch) was an index event. Patients were observed over 6 month pre- and post-index periods. Propensity score matching minimized the selection bias. Results: Buccal film patients had a higher buprenorphine daily dose (501.7 vs 270.9 µg; p < 0.001). The patch-to-film switching rate was higher than vice versa (11.5 vs 3.8%;
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22

Zimmerman, Amanda, Rami Bikdash, and Richard Rauck. "Conversion of Schedule II Opioids to Buprenorphine Buccal Film: A Retrospective Analysis." Pain Medicine, September 11, 2020. http://dx.doi.org/10.1093/pm/pnaa226.

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Abstract Objective To provide clinical data for the conversion of Schedule II opioids to buprenorphine buccal film and to demonstrate sustained analgesia and a reduction in morphine milligram equivalents after conversion. Design Retrospective review of electronic medical records. Setting Group clinical practice providing outpatient chronic pain management care in Winston-Salem, North Carolina. Subjects Patients who received opioids for chronic pain between January 1, 2016, and June 30, 2019, were selected for chart review if they were converted to buprenorphine buccal film from a Schedule II o
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23

Poliwoda, Salomon, Nazir Noor, Jack S. Jenkins, et al. "Buprenorphine and its formulations: a comprehensive review." Health Psychology Research 10, no. 3 (2022). http://dx.doi.org/10.52965/001c.37517.

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Buprenorphine, a novel long-acting analgesic, was developed with the intention of two purposes: analgesia and opioid use disorder. Regarding its pharmacodynamics, it is a partial agonist at mu receptors, an inverse agonist at kappa receptors, and an antagonist at delta receptors. For the purpose of analgesia, three formulations of buprenorphine were developed: IV/IM injectable formulation (Buprenex®), transdermal patch formulation (Butrans®), and buccal film formulation (Belbuca®). Related to opioid dependence, the formulations developed were subcutaneous extended release (Sublocade®), subderm
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24

Stanicic, Filip, Dimitrije Grbic, Djurdja Vukicevic, and Vladimir Zah. "Serious treatment-emergent adverse events in chronic low back pain patients treated with buprenorphine or oral opioids: a retrospective commercial claims analysis." Journal of Comparative Effectiveness Research, July 16, 2024. http://dx.doi.org/10.57264/cer-2023-0183.

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Aim: Explore the safety of Belbuca® (buprenorphine buccal film), buprenorphine transdermal patches and oral opioids for chronic low back pain (cLBP) treatment. Methods: The retrospective analysis of the MarketScan Commercial database (2018–2021) included treatment-naive cLBP adults. The first date of buprenorphine (Belbuca and transdermal patch) or opioid prescription was index date. Cohorts were defined based on the index medication. Observation included a 6-month pre-index period, while post-index lasted until the end of continuous insurance coverage. There were 44 relevant treatment-emergen
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25

Zah, Vladimir, Filip Stanicic, Djurdja Vukicevic, and Dimitrije Grbic. "Economic burden and dosing trends of buprenorphine buccal film and transdermal patch in chronic low back pain." Pain Management, May 31, 2024, 1–13. http://dx.doi.org/10.1080/17581869.2024.2348989.

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26

Webster, Lynn R., Jacqueline Cater, and Thomas Smith. "Pharmacokinetics of Buprenorphine Buccal Film and Orally-administered Oxycodone in a Respiratory Study: An Analysis of Secondary Outcomes from a Randomized Controlled Trial." Pain and Therapy, May 7, 2022. http://dx.doi.org/10.1007/s40122-022-00380-2.

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27

Arnouk, Serena, Jeffrey R. Wunderlich, and S. Alex Sidelnik. "Evaluation of Low-dose Buprenorphine Initiation With Buprenorphine Buccal Films in Hospitalized Patients: A Retrospective Cohort Study." Journal of Addiction Medicine, October 17, 2023. http://dx.doi.org/10.1097/adm.0000000000001236.

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Objective Low-dose buprenorphine initiation (LDBI) strategies to transition patients from full opioid agonists to buprenorphine have previously been described using sublingual films, intravenous solution, transdermal patches, and, more recently, buccal films. The objective of this study was to describe the effectiveness of LDBI using novel titration schedules with buccal films. Methods This is a retrospective cohort study of hospitalized patients with opioid use disorder (OUD) or physiologic dependence to opioids who underwent LDBI with buprenorphine buccal films at NYU Langone Health. Two LDB
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28

Tuan, Wen-Jan, Karl T. Clebak, Elhaam Jawadi, Jessica Snyder, and Aleksandra E. Zgierska. "Risk of Oral Health Problems in Adults with Opioid Use Disorder Treated with Transmucosal Buprenorphine." Journal of Addiction Medicine, March 10, 2025. https://doi.org/10.1097/adm.0000000000001453.

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Objectives In early 2022, based on limited case-report evidence, the US Food and Drug Administration warned about possible oral health problems associated with transmucosal (sublingual, buccal) buprenorphine formulations commonly used to treat opioid use disorder (OUD). The purpose of this study was to assess the risk of adverse oral health outcomes among adults prescribed transmucosal buprenorphine for OUD. Methods This retrospective cohort study utilizing TriNetX claims data consisted of adults diagnosed with OUD in 2002–2019, and who either filled ≥3 transmucosal buprenorphine prescriptions
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29

"Evaluation of Low-dose Buprenorphine Initiation With Buprenorphine Buccal Films in Hospitalized Patients: A Retrospective Cohort Study: Erratum." Journal of Addiction Medicine 18, no. 1 (2024): 95. http://dx.doi.org/10.1097/adm.0000000000001258.

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