In the 12-month period ending in December 2022, over 79,000 people in the U.S.
were reported to have died of an opioid overdose, of which 90% –
approximately 72,000 – were linked to illicit synthetic opioids,
mainly fentanyl1
Approval based on data from a pharmacodynamic
study demonstrating that OPVEE provides fast onset of
reversal of respiratory depression induced by the synthetic
opioid remifentanil2
RICHMOND, Va., May 22, 2023
/PRNewswire/ -- Indivior PLC (LSE: INDV) today announced that
the U.S. Food and Drug Administration (FDA) approved
OPVEE® (nalmefene) nasal spray for the emergency
treatment of known or suspected opioid 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.2 OPVEE contains nalmefene, an opioid
receptor antagonist that provides fast onset and long duration
reversal of opioid-induced respiratory depression, which is the
primary cause of opioid overdose injury and
death.2,3,4 OPVEE was designed to address the
challenges of today's opioid crisis.
"OPVEE's FDA approval represents a significant achievement in
the development of new treatment options to address today's era of
opioid overdoses that are driven by powerful synthetic opioids,
such as fentanyl," said Mark
Crossley, CEO, Indivior. "OPVEE is an emergency treatment
for the fast reversal of respiratory depression triggered by
natural or synthetic opioids, including
fentanyl, 2,3,4 and we are committed to making
this novel rescue medication widely available to those who need it
most to help save lives."
OPVEE was approved via the 505(b)(2) pathway. In a first of its
kind pharmacodynamic study (NCT04828005) in 61 opioid-experienced,
non-dependent subjects, the effect of 2.7 mg OPVEE was assessed on
remifentanil-induced respiratory depression. Following OPVEE
administration, the time to onset of reversal of respiratory
depression was observed between 2.5 to 5 minutes and full recovery
of respiratory drive was manifested as early as 5 minutes after
OPVEE administration. The duration of action of nalmefene is as
long as most opioids, including fentanyl. These attributes are
well-suited to address the challenges of today's opioid overdose
crisis.
"Despite our collective effort to stem opioid abuse in
America, addiction can happen to anyone, and millions of people are
at risk for not only opioid overdose, but also poisoning from
illicit synthetic opioids such as fentanyl," said Jerome Adams, MD, MPH, Executive Director of
Health Equity Initiatives, Purdue
University. "With OPVEE, first responders will have a fast
and long-acting rescue medication option to combat the current
opioid epidemic and save lives."
The speed of action, long duration, and high potency of fentanyl
and other synthetic opioids are driving unprecedented overdose
deaths across a broader range of ages, and they are now a leading
cause of death for people ages 18 to 45.5 For each
opioid-induced fatality, it has been estimated that there are an
additional 6.4-8.4 non-fatal overdoses that can lead to long-term
physical and mental disability.6
"I have seen firsthand the devastating impact of the opioid
crisis on college campuses and in emergency rooms," said
Madeline Hilliard, Founder, Team
Awareness Combating Overdose (TACO) and DopaGE. "The FDA approval
of OPVEE is good news for everyone impacted by the overdose crisis.
In fact, it uses the same device as currently available nasal
overdose reversal agents on the market."
A federally funded contract from the Biomedical Advanced
Research and Development Authority (BARDA), part of the
Administration for Strategic Preparedness and Response within the
US Department of Health and Human Services, for up to $10.8 million, combined with a $7.4 million U01 "grand opportunities in
medications development" grant received from the National Institute
on Drug Abuse (NIDA), supported the development of OPVEE. The
contract (number HHSO100201800029C) with BARDA was intended to
develop OPVEE for reversal of opioid overdoses in the community and
as a medical countermeasure and reversal agent in the event of a
chemical attack using synthetic opioids.
OPVEE is expected to be in the market in Q4 of 2023.
Indivior added OPVEE to its portfolio with the acquisition of
Opiant Pharmaceuticals, Inc., which closed March 2, 2023. As previously indicated, Indivior
believes the clinical profile of OPVEE supports the potential for
this treatment to deliver annual net revenue of $150 million to $250
million, with expected earnings accretion from the Opiant
acquisition after the second full year of launch of OPVEE.
About OPVEE® (nalmefene) Nasal Spray
OPVEE® (nalmefene) nasal spray is an opioid
receptor antagonist approved by the Food and Drug Administration
(FDA) to reverse opioid overdose. OPVEE nasal spray is indicated
for the emergency treatment of known or suspected opioid 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.2
OPVEE contains the opioid receptor antagonist nalmefene, which
works quickly by blocking the brain opioid receptors. In a clinical
model of opioid-induced respiratory depression in
opioid-experienced, non-dependent subjects, OPVEE had an onset of
action of 2.5 to 5 minutes and fully reversed respiratory
depression as early as 5 minutes after OPVEE
administration.2 Other clinical data include a terminal
plasma half-life of approximately 11 hours.2 While the
duration of action of nalmefene is as long as most opioids, a
recurrence of respiratory depression is possible.2 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.
HIGHLIGHTED SAFETY INFORMATION
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 Indivior | Products.
About Indivior
Indivior is a global pharmaceutical company working to help
change patients' lives by developing medicines to treat substance
use disorders (SUD) 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. In
March 2023, Indivior acquired Opiant
Pharmaceuticals, Inc., gaining access to a pipeline focused on
opioid overdose rescue (OPVEE) and other potential SUD treatments.
Opiant Pharmaceuticals entered into the contract with BARDA prior
to the acquisition. Headquartered in the United States in Richmond, VA, Indivior employs more than 900
individuals globally and its portfolio of products is available in
39 countries worldwide. Visit www.indivior.com to learn more.
Connect with Indivior on LinkedIn by visiting
www.linkedin.com/company/indivior.
Cautionary Statement Regarding Forward-Looking
Statements
Important Cautionary Note Regarding Forward-Looking
Statements
This announcement contains certain statements that are
forward-looking. Forward-looking statements include, among other
things, statements regarding the expected safety and efficacy of
OPVEE and the timing of our planned commercial launch of OPVEE, the
potential annual revenue of OPVEE and other statements containing
the words "believe", "anticipate", "plan", "expect", "intend",
"estimate", "forecast," "strategy," "target," "guidance,"
"outlook," "potential", "project", "priority," "may", "will",
"should", "would", "could", "can", "outlook," "guidance", the
negatives thereof, and variations thereon and similar expressions.
By their nature, forward-looking statements involve risks and
uncertainties as they relate to events or circumstances that may or
may not occur in the future.
Actual results may differ materially from those expressed or
implied in such statements because they relate to future events.
Various factors may cause differences between Indivior's
expectations and actual results, including, among others, the
material risks described in the most recent Indivior PLC Annual
Report and in subsequent releases; our ability to commercialize and
market acceptance of new products; the substantial litigation and
ongoing investigations to which we are or may become a party; our
reliance on third parties to manufacture commercial supplies of
most of our products, conduct our clinical trials and at times to
collaborate on products in our pipeline; our ability to comply with
legal and regulatory settlements, healthcare laws and regulations,
requirements imposed by regulatory agencies and payment and
reporting obligations under government pricing programs; risks
related to the manufacture and distribution of our products, some
of which are controlled substances; market acceptance of our
products as well as our ability to commercialize our products and
compete with other market participants; the uncertainties related
to the development of new products, including through acquisitions,
and the related regulatory approval process; our dependence on a
small number of significant customers; our ability to retain key
personnel or attract new personnel; our dependence on third-party
payors for the reimbursement of our products and the increasing
focus on pricing and competition in our industry; unintended side
effects caused by the clinical study or commercial use of our
products; our use of hazardous materials in our manufacturing
facilities; our import, manufacturing and distribution of
controlled substances; our ability to successfully execute
acquisitions, partnerships, joint ventures, dispositions or other
strategic acquisitions; our ability to protect our intellectual
property rights and the substantial cost of litigation or other
proceedings related to intellectual property rights; the risks
related to product liability claims or product recalls; the
significant amount of laws and regulations that we are subject to,
including due to the international nature of our business;
macroeconomic trends and other global developments such as the
COVID-19 pandemic; the terms of our debt instruments, changes in
our credit ratings and our ability to service our indebtedness and
other obligations as they come due; changes in applicable tax rate
or tax rules, regulations or interpretations; and our ability to
realize our deferred tax assets.
Forward-looking statements speak only as of the date that they
are made and should be regarded solely as our current plans,
estimates and beliefs. Except as required by law, we do not
undertake and specifically decline any obligation to update,
republish or revise forward-looking statements to reflect future
events or circumstances or to reflect the occurrences of
unanticipated events.
References and Notes:
- Ahmad FB, Cisewski JA, Rossen LM, Sutton P. Provisional drug
overdose death counts. National Center for Health Statistics. 2023.
https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm.
- OPVEE Prescribing Information. Opiant Pharmaceuticals;
2023.
- Boom M, Niesters M, Sarton E, Aarts L, Smith TW, Dahan A.
Non-analgesic effects of opioids: opioid-induced respiratory
depression. Curr Pharm Des. 2012;18(37):5994-6004. doi:
10.2174/138161212803582469. PMID: 22747535.
- Britch, S.C., Walsh, S.L. Treatment of opioid overdose: current
approaches and recent advances. Psychopharmacology 239,
2063–2081 (2022). https://doi.org/10.1007/s00213-022-06125-5
- "TOP 10 Leading Causes of Death for People Ages 18 to 45 in the
US." Families against Fentanyl, www.familiesagainstfentanyl.org/.
Accessed Oct. 4AD.
- Skolnick P. (2022). Treatment of overdose in the synthetic
opioid era. Pharmacology and Therapeutics.
https://doi.org/10.1016/j.pharmthera.2021.108019
Note: Madeline Hilliard has been
engaged by Indivior to consult for the purposes of the approval of
OPVEE.
Note: Jerome Adams, MD, MPH, has
been engaged by Indivior to consult for the purposes of the
approval of OPVEE.
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