Amneal Announces U.S. FDA Approval of Over-the-Counter Naloxone Hydrochloride Nasal Spray for Emergency Treatment of an Opioid Overdose
Company launches generic equivalent to OTC NARCAN® Nasal Spray
Provides convenient, affordable access to life-saving medicine
“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
Amneal Naloxone HCI Nasal Spray is now available. According to IQVIA®,
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
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in
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
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
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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.
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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/.
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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.
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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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Anthony DiMeo
VP, Investor Relations & Media
anthony.dimeo@amneal.com
Source: Amneal Pharmaceuticals, Inc.