Company Announcements

• BARDA purchased OPVEE, a nalmefene opioid overdose reversal nasal spray
• Through BARDA's contract with Indivior, communities will be better equipped to respond to mass poisoning emergencies and address biosecurity threats involving synthetic opioids

RICHMOND, Va. , Aug. 26, 2024 /PRNewswire/ -- Indivior PLC (LSE/Nasdaq: INDV) today announced the first order of OPVEE^® (nalmefene) nasal spray from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to support its ongoing national preparedness efforts and help save lives during potential synthetic opioid overdose emergencies. OPVEE is the first and only nasal rescue medicine specifically indicated for synthetic opioids like fentanyl.

Opioid overdose deaths continue to claim lives in the U.S. with over 76,922 fatal overdoses in the one-year period ending in January 2024.¹ Access to effective opioid overdose reversal treatments is essential to reducing preventable deaths and helping communities against the evolving threat landscape. 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 United States if medical countermeasure shortages occurred during an emergency response.

"Providing communities with effective tools to address the fentanyl crisis is essential," said Richard Simkin, Chief Commercial Officer and Head of Government Affairs, 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."

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 that 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 the prehospital setting (first responder/EMS) in accidental or intentional mass casualty situations.^2,3 The need for this product is pressing given the increase in fentanyl overdoses in the US.

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50123C00068.

About OPVEE ^®  
OPVEE (nalmefene) nasal spray

INDICATION
OPVEE nasal spray is an opioid antagonist 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.

OPVEE nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present.

OPVEE nasal spray is not a substitute for emergency medical care.

HIGHLIGHTED SAFETY INFORMATION
CONTRAINDICATIONS
Hypersensitivity to nalmefene or to any of the other ingredients.

WARNINGS AND PRECAUTIONS
Risk of Recurrent Respiratory and Central Nervous System Depression: While the duration of action of nalmefene is as long as most opioids, a recurrence of respiratory depression is possible, therefore, keep patient under continued surveillance and administer repeat doses of OPVEE using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance.

Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.

Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal.

Risk of Cardiovascular (CV) Effects: Abrupt postoperative reversal of opioid depression may result in adverse CV effects. These events have primarily occurred in patients who had preexisting CV disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use of nalmefene hydrochloride.

Risk of Opioid Overdose from Attempts to Overcome the Blockade: Attempts to overcome opioid withdrawal symptoms caused by opioid antagonists with high or repeated doses of exogenous opioids may lead to opioid intoxication and death.

ADVERSE REACTIONS
Most common adverse reactions (incidence at least 2%) are nasal discomfort, headache, nausea, dizziness, hot flush, vomiting, anxiety, fatigue, nasal congestion, throat irritation, rhinalgia, decreased appetite, dysgeusia, erythema, and hyperhidrosis.

For more information about OPVEE and the full Prescribing Information visit www.opvee.com

About Indivior

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD), overdose 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 OUD 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 co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

References

1. Ahmad FB, C. J., Rossen LM, Sutton P. (2024). Provisional drug overdose death counts. National Center for Health Statistics, https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm. Accessed April 26, 2024.
2. Karila, L., Marillier, M., Chaumette, B., Billieux, J., Franchitto, N., & Benyamina, A. (2019). New synthetic opioids: Part of a new addiction landscape. Neuroscience & Biobehavioral Reviews/Neuroscience and Biobehavioral Reviews, 106, 133–140. https://doi.org/10.1016/j.neubiorev.2018.06.010
3. Skolnick, P. (2022). Treatment of overdose in the synthetic opioid era. Pharmacology & Therapeutics, 233, 108019. https://doi.org/10.1016/j.pharmthera.2021.108019

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SOURCE Indivior PLC