Company launches generic equivalent to OTC
NARCAN® Nasal Spray
Provides convenient, affordable access to
life-saving medicine
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the
“Company”) today announced the availability of Over the Counter
(“OTC”) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP,
4mg, following Abbreviated New Drug Application (“ANDA”) approval
from the U.S. Food and Drug Administration (“FDA”). Amneal’s
Naloxone HCI Nasal Spray, manufactured in the U.S., is a generic
equivalent to OTC NARCAN® HCI Nasal Spray, a medication that is
widely used to help treat drug overdose from opioids, including
heroin, fentanyl and prescription opioid medications.
“With today’s launch, Amneal is proud to help address this
public health emergency by providing naloxone nasal spray at an
affordable price and without a prescription. Our business is deeply
rooted in a commitment to helping others. By enhancing access to
naloxone nasal spray, we hope to get this affordable emergency
treatment into the hands of even more people who could potentially
save countless families and communities from further heartache and
loss,” said Chirag and Chintu Patel, Co-Chief Executive
Officers.
More than two-thirds of all drug overdose fatalities in 2022
involved illicit, synthetic opioids like fentanyl, which is the
culprit in more deaths under age 50 than any other cause, including
heart disease, cancer, homicide, suicide, and other accidents.1,2
According to the Centers for Disease Control and Prevention, in
about 46% of overdose deaths, another person is present and has the
potential to intervene.3
Amneal Naloxone HCI Nasal Spray is now available. According to
IQVIA®, U.S. annual commercial sales for NARCAN® Naloxone HCl Nasal
Spray 4mg for the 12 months ended February 2024 were $266 million.
In addition, there are significant volumes of the product acquired
directly by U.S. states and municipalities. NARCAN® is a registered
trademark of Emergent Operations Ireland Limited.
About Naloxone Nasal Spray
Naloxone Hydrochloride (Naloxone HCI) Nasal Spray is designed to
rapidly reverse the effects of a life-threatening opioid emergency
by binding to opioid receptors and reversing or blocking the
effects of opioids. It can restore normal breathing within two to
three minutes in a person whose breath has slowed, or even stopped,
as a result of an overdose from opioids — including heroin,
fentanyl and prescription opioid medications. Naloxone HCI Nasal
Spray contains the same active ingredient and dose as NARCAN®
Naloxone HCI Nasal Spray, 4 mg. It is easy to carry and can be
safely used even if opioids are not present.
When using this product some people may experience symptoms when
they wake up, such as shaking, sweating, nausea, or feeling angry.
This is to be expected.
About the Opioid Crisis
The opioid epidemic was declared a national public health
emergency in 2017 and has continually been renewed by the U.S.
Secretary of Health and Human Services.4,5 Ending the epidemic is a
top strategic priority of the U.S. government and Congress.6 Since
2000, about one million people in the U.S. have died of drug
overdoses, the majority of which were due to opioids.7,8 Drivers of
this crisis include the misuse of prescription pain medication and
the unwitting use of drugs laced with fentanyl — which is 50 times
more potent than heroin and 100 times more potent than morphine.9
In 2022, roughly twice as many people died in the U.S. from
opioid-related overdoses than from motor vehicle crashes.10,11
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in
Bridgewater, NJ, is a global pharmaceuticals company. We make
healthy possible through the development, manufacturing, and
distribution of a diverse portfolio of over 270 pharmaceutical
products, primarily within the United States. In its Generics
segment, the Company is expanding across a broad range of complex
product categories and therapeutic areas, including injectables and
biosimilars. In its Specialty segment, Amneal has a growing
portfolio of branded pharmaceuticals focused primarily on central
nervous system and endocrine disorders, with a pipeline focused on
unmet needs. Through its AvKARE segment, the Company is a
distributor of pharmaceuticals and other products for the U.S.
federal government, retail, and institutional markets. For more
information, please visit www.amneal.com.
Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are
not historical facts, may be forward-looking statements (as defined
in the U.S. Private Securities Litigation Reform Act of 1995). Such
forward-looking statements include statements regarding
management’s intentions, plans, beliefs, expectations, financial
results, or forecasts for the future, including among other things:
discussions of future operations; expected or estimated operating
results and financial performance; and statements regarding our
positioning, including our ability to drive sustainable long-term
growth, and other non-historical statements. Words such as “plans,”
“expects,” “will,” “anticipates,” “estimates,” and similar words,
or the negatives thereof, are intended to identify estimates and
forward-looking statements.
The reader is cautioned not to rely on these forward-looking
statements. These forward-looking statements are based on current
expectations of future events, including with respect to future
market conditions, company performance and financial results,
operational investments, business prospects, new strategies and
growth initiatives, the competitive environment, and other events.
If the underlying assumptions prove inaccurate or known or unknown
risks or uncertainties materialize, actual results could vary
materially from the expectations and projections of the
Company.
Such risks and uncertainties include, but are not limited to:
our ability to successfully develop, license, acquire and
commercialize new products on a timely basis; the competition we
face in the pharmaceutical industry from brand and generic drug
product companies, and the impact of that competition on our
ability to set prices; our ability to obtain exclusive marketing
rights for our products; our revenues are derived from the sales of
a limited number of products, a substantial portion of which are
through a limited number of customers; the impact of a prolonged
business interruption within our supply chain; the continuing trend
of consolidation of certain customer groups; our dependence on
third-party suppliers and distributors for raw materials for our
products and certain finished goods; legal, regulatory and
legislative efforts by our brand competitors to deter competition
from our generic alternatives; our dependence on information
technology systems and infrastructure and the potential for
cybersecurity incidents; our ability to attract, hire and retain
highly skilled personnel; risks related to federal regulation of
arrangements between manufacturers of branded and generic products;
our reliance on certain licenses to proprietary technologies from
time to time; the significant amount of resources we expend on
research and development; the risk of claims brought against us by
third parties; risks related to changes in the regulatory
environment, including U.S. federal and state laws related to
healthcare fraud abuse and health information privacy and security
and changes in such laws; changes to Food and Drug Administration
product approval requirements; the impact of healthcare reform and
changes in coverage and reimbursement levels by governmental
authorities and other third-party payers; our dependence on
third-party agreements for a portion of our product offerings; our
substantial amount of indebtedness and our ability to generate
sufficient cash to service our indebtedness in the future, and the
impact of interest rate fluctuations on such indebtedness; our
potential expansion into additional international markets
subjecting us to increased regulatory, economic, social and
political uncertainties, including recent events affecting the
financial services industry; our ability to identify, make and
integrate acquisitions or investments in complementary businesses
and products on advantageous terms; the impact of global economic,
political or other catastrophic events; our obligations under a tax
receivable agreement may be significant; and the high concentration
of ownership of our class A common stock and the fact that we are
controlled by the Amneal Group. The forward-looking statements
contained herein are also subject generally to other risks and
uncertainties that are described from time to time in the Company’s
filings with the Securities and Exchange Commission, including
under Item 1A, “Risk Factors” in the Company’s most recent Annual
Report on Form 10-K and in its subsequent reports on Forms 10-Q and
8-K. Investors are cautioned not to place undue reliance on any
such forward-looking statements, which speak only as of the date
they are made. Forward-looking statements included herein speak
only as of the date hereof and we undertake no obligation to revise
or update such statements to reflect the occurrence of events or
circumstances after the date hereof.
- Mbabazi Kariisa, PhD; Julie O’Donnell, PhD; Sagar Kumar, MPH;
Christine L. Mattson, PhD; Bruce A. Goldberger, PhD. (2023).
“Illicitly Manufactured Fentanyl–Involved Overdose Deaths with
Detected Xylazine — United States, January 2019–June 2022.”
Morbidity and Mortality Weekly Report. Weekly / June 30, 2023 /
72(26);721–727.
https://www.cdc.gov/mmwr/volumes/72/wr/mm7226a4.htm#:~:text=In%202022%2C%20provisional%20data%20indicated,(IMFs)%20(1).
- United States Drug Enforcement Administration. (2024). Fentanyl
Awareness. [Fact Sheet].
https://www.dea.gov/fentanylawareness.
- Centers for Disease Control and Prevention. Drug Overdose.
SUDORS Dashboard: Fatal Overdose Data. (2022). Potential
opportunities for intervention in 2021.
https://www.cdc.gov/drugoverdose/fatal/dashboard/index.html.
- U.S. Department of Health and Human Services. (2017).
Determination That a Public Health Emergency Exists.
https://aspr.hhs.gov/legal/PHE/Pages/opioids.aspx.
- U.S. Department of Health and Human Services. (2023).
Declarations of a Public Health Emergency.
https://aspr.hhs.gov/legal/PHE/Pages/default.aspx.
- The White House. (2022). President Biden Releases National Drug
Control Strategy to Save Lives, Expand Treatment, and Disrupt
Trafficking.
https://www.whitehouse.gov/ondcp/briefing-room/2022/04/21/president-biden-releases-national-drug-control-strategy-to-save-lives-expand-treatment-and-disrupt-trafficking/.
- Council on Foreign Relations. (2023). Fentanyl and the U.S.
Opioid Epidemic. [Backgrounder].
https://www.cfr.org/backgrounder/fentanyl-and-us-opioid-epidemic.
- Centers for Disease Control and Prevention. (2022). Drug
Overdose. Death Rate Maps and Graphs.
https://www.cdc.gov/drugoverdose/deaths/index.html.
- American Psychiatric Association. (2022) Opioid Use Disorder.
[Backgrounder].
https://www.psychiatry.org/patients-families/opioid-use-disorder.
- Centers for Disease Control and Prevention. (2023). Provisional
Data Shows U.S. Drug Overdose Deaths Top 100,000 in 2022.
https://blogs.cdc.gov/nchs/2023/05/18/7365/#:~:text=The%20only%20state%20in%20which,82%2C310%20in%20the%20previous%20year.
- United States Department of Transportation. (2023) NHTSA
Estimates for 2022 Show Roadway Fatalities Remain Flat After Two
Years of Dramatic Increases. [Press Release].
https://www.nhtsa.gov/press-releases/traffic-crash-death-estimates-2022#:~:text=The%20National%20Highway%20Traffic%20Safety,42%2C939%20fatalities%20reported%20for%202021.
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version on businesswire.com: https://www.businesswire.com/news/home/20240424236083/en/
Anthony DiMeo VP, Investor Relations & Media
anthony.dimeo@amneal.com
Amneal Pharmaceuticals (NYSE:AMRX)
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