Sandoz launches authorized generic of Narcan® (naloxone hydrochloride) Nasal Spray 4 mg in US to help reverse opioid overdose, expanding access during surge in overdose deaths

PRINCETON, N.J., Dec. 22, 2021 /PRNewswire/ -- Sandoz, a global leader in generic and biosimilar medicines, today announced the US launch of its authorized generic of Narcan^® (naloxone hydrochloride)^* Nasal Spray 4mg, which is used to reverse opioid overdose.³ It is immediately available to people in the US via retail pharmacies and institutions, including hospitals.

Approximately every 8 minutes in the US a life is lost to an opioid overdose.⁴ Opioid dependency and accidental opioid overdoses are a serious national crisis affecting public health and social and economic welfare. Opioid overdose death rates have been continuously increasing in the US for over two decades.⁵

During the COVID-19 pandemic, increased stressors such as isolation, unemployment and illness -- along with disruptions in health care and obstacles obtaining treatment -- have put people at increased risk of opioid overdose.⁶  Of the 49 million patients prescribed opioids in the US, more than 18 million are considered at-risk, but only five percent received a prescription for naloxone.⁷

"Now more than ever, it's imperative that Americans have increased access to life-saving opioid overdose reversal medicines for themselves or a loved one," said Keren Haruvi, President, Sandoz Inc. "The launch of our authorized generic of Narcan^® Nasal Spray reinforces our commitment to delivering high-quality, affordable generic medicines and to do our part to help address the public health epidemic for people at risk for opioid overdose."

In July 2020, the US Food and Drug Administration (FDA) issued recommendations to healthcare professionals (HCPs) encouraging them to discuss the availability of naloxone with patients at increased risk of opioid overdose, which includes certain patients taking opioid pain relievers or medicines to treat opioid use disorder.⁸ FDA has also identified situations in which an HCP may give strong consideration to prescribing naloxone, e.g., for patients prescribed medications for opioid use disorder or if the patient's household has members at risk for accidental opioid ingestion or overdose.⁹

All 50 states in the US allow for access to the 4 mg naloxone hydrochloride nasal spray either directly from a pharmacist without a prescription under a Statewide Standing Order, a Collaborative Practice Agreement between pharmacists and other health care providers or through a third-party prescription that allows someone other than the patient to obtain the 4 mg naloxone hydrochloride nasal spray to assist an at risk individual.¹⁰ Family and friends are often in the best position to administer this potentially lifesaving drug to those who overdose. State laws vary for eligibility and distribution.¹¹

To learn more about the Sandoz naloxone hydrochloride authorized generic, visit www.sandoz-naloxone.com.

*Narcan is a registered trademark of Emergent Operation Ireland Limited.

INDICATION AND USAGE 

Naloxone HCl Nasal Spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. Naloxone HCl Nasal Spray is not a substitute for emergency medical care. 

IMPORTANT SAFETY INFORMATION 
Naloxone HCl Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients. 

Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance. 

Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer repeat doses of naloxone using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance. 

Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/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 characterized by body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. In some patients, there may be aggressive behavior upon abrupt reversal of an opioid overdose. Monitor for the development of opioid withdrawal. 

In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may also include convulsions, excessive crying, and hyperactive reflexes. 

Abrupt Postoperative Reversal of Opioid Depression: Abrupt postoperative reversal of opioid depression may result in nausea, vomiting, sweating, tremulousness, tachycardia, hypotension, hypertension, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest. Serious sequelae of these events, including coma and death, have been reported. These events have primarily occurred in patients who had pre-existing cardiovascular (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 naloxone HCl. 

Adverse Reactions: The following adverse reactions were observed in a Naloxone HCl Nasal Spray clinical study: increased blood pressure, constipation, toothache, muscle spasms, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, nasal inflammation, rhinalgia, and xeroderma. 

Please see full Prescribing Information for additional safety information. 

Disclaimer 
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product's label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Sandoz
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical need. Our ambition is to be the world's leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2020 sales of USD 9.6 billion.

Sandoz on social media
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CEO Richard Saynor on LinkedIn: https://www.linkedin.com/in/richard-saynor/

References
1. Centers for Disease Control and Prevention. National Center for Health Statistics. Vital Statistics Rapid Release Provisional Drug Overdose Death Counts. Available at: https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm#dashboard. Accessed on July 20, 2021.
2. Centers for Disease Control and Prevention.  Newsroom. Overdose Deaths Accelerating During COVID-19 [press release]; December 17, 2020. Available at: https://www.cdc.gov/media/releases/2020/p1218-overdose-deaths-covid-19.html. Accessed on June 3, 2021.
3. Naloxone hydrochloride nasal spray. Prescribing information. Available at: https://sandoz-naloxone.com/pdf/naloxone-pi.pdf. Accessed December 22, 2021.
4. Centers for Disease Control and Prevention. Provisional Drug Overdose Death Counts. Available at:https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm. Accessed October 22, 2021.
5. National Institute on Drug Abuse (NIDA). Overdose Death Rates. Available at: https://www.drugabuse.gov/drug-topics/trends-statistics/overdose-death-rates. Accessed on May 26, 2021.
6. Drug Free America Foundation, Inc. Impacts of COVID-19 on Substance Use, Opioid Overdose, and Treatment. Available at: https://www.dfaf.org/impacts-of-covid-19-on-substance-use-opioid-overdose-and-treatment/. Accessed on May 26, 2021.
7. Data extracted from IQVIA Pharmacy Claims Database in the retail and mail channels for the 12 months of August 2018 through July 2019.
8. US Food and Drug Administration. FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-recommends-health-care-professionals-discuss-naloxone-all-patients-when-prescribing-opioid-pain. Accessed on July 20, 2021.
9. US Food and Drug Administration. New Recommendations for Naloxone. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/new-recommendations-naloxone. Accessed on June 24, 2021.
10. Legislative Analysis and Public Policy Association. Naloxone Access: Summary of State Laws. Available at: https://legislativeanalysis.org/wp-content/uploads/2020/10/Naloxone-summary-of-state-laws-FINAL-9.25.2020.pdf. Accessed on July 20, 2021.
11. SAFE Project. State Naloxone Access Rules and Resources. Available at: https://www.safeproject.us/naloxone-awareness-project/state-rules/. Accessed on May 26, 2021.

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