REG - Indivior PLC - US FDA Approves OPVEE

IndiviorAnnouncement

23/05/2023 07:00

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RNS Number : 3243A  Indivior PLC  23 May 2023

Indivior Announces U.S. Food and Drug Administration Approval of OPVEE®
(nalmefene) Nasal Spray, An Opioid Overdose Rescue Medicine for Natural and
Synthetic Opioids Like Fentanyl

 

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 fentanyl(1)

 

Approval based on data from a pharmacodynamic study demonstrating that OPVEE
provides fast onset of reversal of respiratory depression induced by the
synthetic opioid remifentanil(2)

 

Richmond, Va., May 23, 2023 - 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
(https://clinicaltrials.gov/ct2/show/NCT04828005?term=Opiant&draw=2&rank=2)
) 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. For more information
about OPVEE, including full Prescribing Information visit www.opvee.com
(http://www.opvee.com) .

 

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
www.opvee.com (http://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) 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.

 

Contacts:

Media:

RXMD

(646) 247-3405

 

Investors and Analysts:

Jason Thompson

Vice President, Investor Relations

Indivior PLC

Mobile: 804-402-7123

 

Tim Owens

Director, Investor Relations

Indivior PLC

Mobile: 804-263-3978

 

 

References and Notes:

1.   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
(https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm) ).

2.   OPVEE Prescribing Information. Opiant Pharmaceuticals; 2023.

3.   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.

4.   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
(https://doi.org/10.1007/s00213-022-06125-5)

5.   "TOP 10 Leading Causes of Death for People Ages 18 to 45 in the US."
Families against Fentanyl, www.familiesagainstfentanyl.org/
(http://www.familiesagainstfentanyl.org/) . Accessed Oct. 4AD.

6.   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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