Health And Human Services Dept Orders OPVEE Nasal Spray For Emergency Fentanyl Overdose Response

Indivior PLC (NASDAQ:INDV) confirmed the first order of the OPVEE (nalmefene) nasal spray from the Biomedical Advanced Research and Development Authority (BARDA), which is the Department of Health and Human Services’ office responsible for procurement and development of medical countermeasures.

The global pharmaceutical company focused on developing medicines to treat substance use disorders (SUD) and serious mental illnesses said that OPVEE is the first and only nasal rescue medicine specifically indicated for synthetic opioids like fentanyl.

According to data from the Substance Abuse and Mental Health Services Administration, fentanyl is widespread in the illicit drug supply and more common than heroin. Overdose deaths are at historically high levels nationwide with over 108,000 people dying from overdose in 2022, as per data released by the Centers for Disease Control and Prevention (CDC). What's more, in the one-year period ending in January 2024, there were over 76,922 fatal overdoses.

With its first order of OPVEE, BARDA will be able to supplement local supplies of emergency opioid overdose medications for emergency rooms, ambulances, and other sites in the U.S. if medical countermeasure shortages occur during an emergency response.

“Providing communities with effective tools to address the fentanyl crisis is essential,” stated Richard Simkin, chief commercial officer and head of government affairs at Indivior. “This order of OPVEE has the potential to support the nation’s preparedness against potential biothreats and response efforts to reduce overdose deaths from fentanyl and other synthetic opioid poisonings.”

Read Also: Biden Administration Calls Fentanyl Laced With Xylazine ‘Emerging Threat,’ What Now?

$8.7M In Project BioSheild

BARDA's order of OPVEE comes some five months after Indivior announced the results from a pharmacodynamic study demonstrating the spray's rapid reverse of opioid-induced respiratory depression, the major cause of death due to opioid overdose. The findings showed that OPVEE reversed the respiratory depression produced by remifentanil – which is a synthetic opioid related to fentanyl – during the first 5 minutes following the administration.

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BARDA will use $8.7 million in Project BioShield designated funding for the initial procurement. The first option was exercised under the agreement with Indivior which was announced in December 2023. BARDA has the option to purchase additional OPVEE annually under Indivior vendor- managed inventory over the next nine years.

OPVEE would be used in prehospital settings (first responder/EMS) in accidental or intentional mass casualty situations.

This project was funded in whole or part with federal funds from the Department of Health and Human Services, Administration for Strategic Preparedness and Response and BARDA.

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