The number of opioid overdose deaths in the United States has continued to increase for more than two decades. Illicitly manufactured synthetic opioids (“synthetics”) such as fentanyl have been linked to >90% of the more than 74,000 opioid overdose deaths reported for the 12 months ending in March 2024. This surge in deaths from illicitly manufactured opioids prompted further research on reversal agents. Intranasal nalmefene is a recently FDA-approved formulation indicated for the emergency treatment of known or suspected overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression. A validated translational model that was previously developed by Mann et al (2022) to predict opioid-induced respiratory depression and cardiac arrest, was leveraged to include intranasal nalmefene and intranasal naloxone data and perform additional simulations. The model was then utilized to compare the predicted incidence of cardiac arrest events after a synthetic opioid overdose with fentanyl and carfentanil and subsequent rescue by intranasal administration of either naloxone (gold standard reversal agent) or nalmefene.

Please join us for an insightful webinar, where international academic and modeling experts will converge to discuss the validity and robustness of the modeling approach and the learnings from the model application in the context of the current opioid crisis.

The webinar aims to achieve the following objectives:

1. Provide an overall view of the clinical need for opioid reversal agents
2. Inform the clinical audience on the current available treatments
3. Discuss the updated model published in the Laffont paper
4. Compare the cardiac arrest predictions for both intranasal reversal agents (naloxone and nalmefene)
5. Address scientific questions

Our distinguished panel of speakers includes:

Two experts in the PK/PD modeling arena to provide comprehensive perspectives on the translational model from the publication: “Comparison of intranasal naloxone and intranasal nalmefene in a translational model assessing the impact of synthetic opioid overdose on respiratory depression and cardiac arrest” which was expanded from the model described in the Mann et al. manuscript “Development of a Translational Model to Assess the Impact of Opioid Overdose and Naloxone Dosing on Respiratory Depression and Cardiac Arrest.”

Two international clinical experts from academia and an independent addiction consultant, providing an overview of the current clinical needs for opioid reversal agents and sharing their insights on the clinical relevance of these agents.

• Daniel González, Ph.D. (Clinical Pharmacologist and Pharmacometrician) 
• Zhihua Li, Ph.D. (Pharmacokineticist, FDA) 
• Edward Boyer, M.D., Ph.D. (Professor of Emergency Medicine, The Ohio State University Wexner Medical Center) 
• Albert Dahan, M.D., Ph.D. (Professor, Leiden University Medical Center)
• Mark Gold, M.D. (Independent Addiction Consultant)
• Amparo de la Peña, Ph.D. (VP of Pharmacometrics, Simulations Plus) – Moderator