- 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
-
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.
-
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). Treatment
of overdose in the synthetic
opioid era. Pharmacology & Therapeutics, 233,
108019. https://doi.org/10.1016/j.pharmthera.2021.108019
View original content to download
multimedia:https://www.prnewswire.com/news-releases/indivior-announces-bardas-first-order-of-opvee-to-combat-opioids-and-aid-in-national-preparedness-302230473.html
SOURCE Indivior PLC