- BARDA purchased OPVEE, a nasal spray used to treat opioid overdoses of nalmefene.
- Through the BARDA-Indivior agreement, communities will be better prepared to respond to mass poisonings and address biosecurity threats related to synthetic opioids.
RICHMOND, Virginia., 26 August 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 ongoing national preparedness efforts and save lives during potential synthetic opioid emergencies. OPVEE is the first and only nasal emergency medication specifically designed for synthetic opioids such as fentanyl.
Deaths from opioid overdoses continue to occur in the United States. In the one-year period ending in 2018, there were over 76,922 fatal overdoses. January 2024.1 Access to effective treatments to manage opioid overdose is critical to reducing preventable deaths and helping communities combat the evolving threat landscape. With its first order of OPVEE, BARDA can increase the local supply of opioid overdose medications for emergency departments, outpatient clinics, and other settings in the United States if there are shortages of medical countermeasures during an emergency operation.
“It is critical to provide communities with effective tools to address the fentanyl crisis,” said Richard SimkinChief Commercial Officer and Director of Government Affairs, Indivior. “This OPVEE order can support the nation’s preparedness for potential biothreats and response efforts to reduce overdose deaths from fentanyl and other synthetic opioids.”
BARDA is 8.7 million US dollars in the BioShield project, funds were allocated for the first procurement. The first option was exercised under the agreement with Indivior, which was December 2023BARDA has the option to purchase additional OPVEE from Indivior annually for the next nine years as part of the supplier-managed inventory.
OPVEE would be used in the pre-hospital setting (first responders/emergency services) in the event of accidental or intentional mass casualty incidents.2.3 Given the increase in fentanyl overdoses in the United States, the need for this product is urgent.
This project was 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 No. 75A50123C00068.
About OPVEE®
OPVEE (nalmefene) nasal spray
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OPVEE Nasal Spray is an opioid antagonist for the emergency treatment of known or suspected natural or synthetic opioid overdose in adults and children aged 12 years and older, manifested by respiratory and/or central nervous system depression.
OPVEE Nasal Spray is intended for immediate administration as emergency therapy in situations where opioids may be present.
OPVEE Nasal Spray is not a substitute for emergency medical care.
Highlighted safety information
Contraindications
Hypersensitivity to nalmefene or any of the other ingredients.
WARNINGS AND PRECAUTIONS
Risk of recurrent respiratory and central nervous system depression: Although the duration of action of nalmefene is as long as that of most opioids, recurrence of respiratory depression is possible. Therefore, keep the patient under continuous observation and, if necessary, administer multiple doses of OPVEE, using a new nasal spray for each dose, while awaiting emergency medical assistance.
Limited efficacy with partial agonists or mixed agonists/antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists such as buprenorphine and pentazocine may be incomplete. Higher or repeated doses may be required.
Triggers of severe opioid withdrawal: Use in patients who are opioid dependent may result in opioid withdrawal. In neonates, opioid withdrawal can 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 cardiovascular effects. These events have occurred primarily in patients with a history of cardiovascular disease or receiving other medications that may cause similar adverse cardiovascular effects. Monitor these patients closely in an appropriate medical setting following administration of nalmefene hydrochloride.
Risk of opioid overdose when attempting to overcome the blockageAttempts to overcome opioid withdrawal symptoms caused by opioid antagonists with high or repeated doses of exogenous opioids may result in opioid poisoning and death.
SIDE EFFECTS
The most common side effects (frequency at least 2%) are nasal discomfort, headache, nausea, dizziness, hot flushes, vomiting, anxiety, fatigue, nasal congestion, throat irritation, rhinitis, decreased appetite, dysgeusia, erythema and hyperhidrosis.
For more information about OPVEE and full prescribing information, visit www.opvee.com
About Indivior
Indivior is a global pharmaceutical company working to transform patients’ lives by developing medicines to treat substance use disorders (SUD), overdoses and serious mental illness. Our vision is for all patients around the world to have access to evidence-based treatments for the chronic conditions and comorbidities of SUD. Indivior is committed 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 its legacy in the category and potentially treat other chronic conditions and comorbidities of SUD, including alcohol and cannabis use disorders. Headquartered in the United States In Richmond, VirginiaIndivior employs over 1,000 people worldwide and its product portfolio is available in over 30 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by www.linkedin.com/company/individor.
References
- Ahmad FB, CJ, Rossen LM, Sutton P. (2024). Preliminary numbers of drug overdose deaths. National Center for Health Statistics, https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htmRetrieved April 26, 2024.
- 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
- Skolnick, P. (2022). Treating overdose in the era of synthetic opioids. Pharmacology & Therapeutics, 233, 108019. https://doi.org/10.1016/j.pharmthera.2021.108019
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