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Indivior Announces the Publication of New Data on the Comparative Effectiveness of Intranasal (IN) Nalmefene (OPVEE 2.7mg) and IN Naloxone (4 mg) in a Translational Model Assessing the Impact of a Synthetic Opioid Overdose on Respiratory Depression an...
Indivior Announces the Publication of New Data on the Comparative Effectiveness of Intranasal (IN) Nalmefene (OPVEE 2.7mg) and IN Naloxone (4 mg) in a
About this update from Indivior Pharmaceuticals, Inc.
[{"type":"text","content":"Indivior Announces the Publication of New Data on the Comparative Effectiveness of Intranasal (IN) Nalmefene (OPVEE 2.7mg) and IN Naloxone (4 mg) in a Translational Model Assessing the Impact of a Synthetic Opioid Overdose on Respiratory Depression and Cardiac Arrest \n \n\nLarge reductions in the incidence of simulated cardiac arrest caused by potentially lethal doses of fentanyl or carfentanil were observed following a single IN dose of OPVEE compared to a single dose of IN naloxone. Across scenarios of fentanyl or carfentanil overdoses, simultaneous administration of four doses of IN naloxone (4×4 mg) was needed to reduce the incidence of simulated cardiac arrest to values approaching those obtained with a single dose of OPVEE (3mg). Modeling predictions in chronic opioid users indicate that the incidence of cardiac arrest following an intravenous (IV) fentanyl overdose (2.97 mg) decreased from 78% in the absence of intervention to 12% with OPVEE and 47% with a 4 mg IN dose of naloxone. RICHMOND, Va., June 18, 2024 /PRNewswire/ -- Indivior PLC (LSE/Nasdaq: INDV) today announced the publication of a modeling study in Frontiers in Psychiatry that predicts OPVEE (nalmefene) nasal spray (2.7 mg nalmefene, equivalent to 3 mg of nalmefene hydrochloride) resulted in larger reductions in the incidence of simulated cardiac arrest following overdose from high doses of potent synthetic opioids, compared to a 4 mg dose of IN naloxone.\n\n \n \n \n \n \n \n\n \nModel simulations were performed using a validated translational model1 developed by the Division of Applied Regulatory Science in the US Food and Drug Administration's Center for Drug Evaluation and Research. In the present study, this translational model was further expanded with data from pharmacokinetic and pharmacodynamic studies with OPVEE2,3 and IN naloxone pharmacokinetic data.2 Simulations were conducted in 2000 virtual patients. Following an IV dose of 2.97 mg fentanyl that resulted in a 78% incidence of cardiac arrest in chronic opioid users, a single administration of 4 mg IN naloxone reduced this rate to 47% while a single dose of IN OPVEE reduced this rate to 12%. Four simultaneous doses of 4 mg IN naloxone were needed to lower the incidence of cardiac arrest to 17% which was comparable to that observed following a single dose of OPVEE (12%).\nSimulations in opioid na...