Abstract posters will be displayed in the Exhibit Hall beginning on Wednesday 9/4 at 10:30am
P-121 - A Review of the Primary and Secondary Outcomes From a Phase I Study Comparing the Respiratory Effects of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride Administration
Director of Medical Affairs Collegium Pharmaceutical Stoughton, Massachusetts
Abstract Title: A Review of the Primary and Secondary Outcomes From a Phase I Study Comparing the Respiratory Effects of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride Administration
Background: Overdose by respiratory depression, from abuse or medical use, is a major concern with opioids.1,2 Buprenorphine buccal film (BBF) is a partial μ-opioid receptor agonist that, unlike full μ-opioid receptor agonists, has shown a ceiling effect on respiratory depression.3-5
Purpose/Objectives: This is a review of published respiratory depression data from a phase 1 study published in 2020 and 2022. The study was conducted to compare the effects of BBF and oxycodone immediate-release (IR) administration on respiratory drive, pharmacokinetics (PK) parameters, oxygen saturation, and pupillary-constricting effects.6-8
Methods: This randomized, double-blind, placebo-controlled, double-dummy crossover study enrolled 19 healthy participants who self-identified as recreational users of opioids, with 15 participants completing the study. Participants were administered 300, 600, and 900 μg BBF; 30 and 60 mg oxycodone IR; and placebo.6-8
Results: Respiratory depression (maximum decrease in minute ventilation) did not decrease significantly with BBF relative to placebo.6 Oxycodone 60 mg resulted in a significant, dose-dependent decrease in respiratory drive (P = 0.01). Time to peak drug concentration was similar between doses for each individual drug, while the mean decrease in oxygen saturation was greater for oxycodone compared with BBF.7 Although similar pupil constriction levels were observed, miosis was delayed with BBF compared with oxycodone.8
Conclusions/Implications for future research and/or clinical care: This review of study endpoints from the phase 1 study suggests BBF may exhibit an improved respiratory safety profile relative to oxycodone IR, but additional studies need to be conducted.
References: 1.Dolinak D. Opioid toxicity. Acad Forensic Pathol. 2017;7(1):19–35.
2.Pattinson KT. Opioids and the control of respiration. Br J Anaesth. 2008;100(6):747–58.
3.Dahan A, Yassen A, Bijl H, et al. Comparison of the respiratory effects of intravenous buprenorphine and fentanyl in humans and rats. Br J Anaesth. 2005;94(6):825–34.
4.Dahan A, Yassen A, Romberg R, et al. Buprenorphine induces ceiling in respiratory depression but not in analgesia. Br J Anaesth. 2006;96(5):627–32.
5.Khanna IK, Pillarisetti S. Buprenorphine - an attractive opioid with underutilized potential in treatment of chronic pain. J Pain Res. 2015;8: 859–70.
6.Webster LR, Hansen E, Cater J, et al. A Phase I placebo-controlled trial comparing the effects of buprenorphine buccal film and oral oxycodone hydrochloride administration on respiratory drive. Adv Ther. 2020;37(11):4685–4696.
7.Webster LR, Hansen E, Smith T. Pharmacokinetics of buprenorphine buccal film and orally-administered oxycodone in a respiratory study: an analysis of secondary outcomes from a randomized controlled trial. Pain Ther. 2022;11(3):817-825.
8.Webster LR, Hansen E, Smith T. Effects of buprenorphine buccal film and oral oxycodone on pupil diameter in a respiratory study. J Opioid Manag. 2022;18(2):181-190.
