Indivior Presents Modelling Data on Interaction Between Buprenorphine and Fentanyl in Opioid-Naïve and Opioid-Tolerant Subjects at the 2021 American Conference of Pharmacometrics
Data explain how buprenorphine has the potential to reduce the frequency and magnitude of fentanyl-induced respiratory depression and apnea
Richmond, VA, November 8, 2021 - Indivior PLC (LON: INDV) announces the presentation of modelling data describing the competitive interaction of buprenorphine, a treatment for opioid use disorder (OUD), and fentanyl, an increasingly abused opioid, at the µ-opioid receptor (MOR) at the Twelfth American Conference of Pharmacometrics (ACoP12), taking place virtually from November 8-12, 2021.
According to the Centers for Disease Control and Prevention (CDC), more than 96,779 people died from drug overdose in the 12-month period ending March 2021. Approximately 61,230 of these deaths were attributed to synthetic opioids such as fentanyl.1
Modelling Buprenorphine Effect on Fentanyl-induced Respiratory Depression in Opioid-naïve and Opioid-tolerant Subjects explains how buprenorphine has the potential to reduce fentanyl-induced respiratory depression and apnea.2 Population pharmacokinetic/pharmacodynamic (PK/PD) modelling was conducted to characterize buprenorphine-fentanyl interaction at MORs and its resulting effect on ventilation.2 This modelling suggested that clinically relevant exposures to buprenorphine has the potential to limit fentanyl binding to MORs and thereby possibly reduce the frequency and magnitude of respiratory depression induced by fentanyl in opioid-tolerant (OT) subjects.2
“This modelling study further enhances our understanding of the competitive interaction between buprenorphine and fentanyl,” said Christian Heidbreder, Chief Scientific Officer, Indivior. “The study results provide early clinical insights into the role that high sustained buprenorphine plasma concentrations may have in reducing fentanyl-induced respiratory depression and apnea. Because of these promising data, additional study is warranted.”
About the Study
In this two-period crossover, single-center study, 14 opioid-naïve healthy volunteers (HV) and 8 OT subjects received on 2 separate occasions intravenous placebo and buprenorphine infusion targeting buprenorphine plasma concentrations of 0.2 or 0.5 ng/mL in HVs and 1, 2 or 5 ng/mL in OT subjects.1 Upon reaching target concentrations, participants received up to 4 escalating intravenous doses of fentanyl (HV: 0.075–0.35 mg/70 kg; OT: 0.25–0.70 mg/70 kg). Minute ventilation was measured under isohypercapnic conditions and serial blood samples were collected to assess buprenorphine and fentanyl plasma concentrations. Simulation studies were conducted to investigate the effects of a larger range of fentanyl bolus doses (up to 5 mg/70 kg) that may be representative of fentanyl unintentional overdoses.2
About Indivior
Indivior is a global pharmaceutical company working to help change patients’ lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and cooccurring disorders of SUD. Headquartered in the United States in Richmond, VA, Indivior employs more than 800 individuals globally and its portfolio of products is available in over 40 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.
Forward-Looking Statements
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References:
- Ahmad FB, Rossen LM, Sutton P. Provisional drug overdose death counts. National Center for Health Statistics; 2021 (last updated 10/3/2021). https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
- Olofsen E, Hyke Algera M, Moss L et al. (2021) Modeling Modelling Buprenorphine Effect on Fentanyl-induced Respiratory Depression in Opioid-naïve and Opioid-tolerant Subjects. ACoP 2021