Emergent BioSolutions Announces Shelf-Life Extension From 36 Months (Three Years) to 48 Months (Four Years) for NARCAN® Nasal Spray
- With its proprietary four-year stability data, Emergent prioritized the shelf-life extension of NARCAN® Nasal Spray to help combat the opioid overdose epidemic
GAITHERSBURG, Md., January 18, 2024 – Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the shelf-life extension of NARCAN® Nasal Spray from 36 months (three years) to 48 months (four years) based on the company’s four-year stability data. NARCAN® Nasal Spray is the only prescription strength, 4 mg, over-the-counter (OTC) intranasal naloxone spray in the U.S. with this expanded expiration date. The four-year expiration will apply to newly manufactured product that is planned to be released by Emergent in late first quarter or early second quarter of this year. Emergent encourages all customers and consumers to follow the expiration date printed on the product packaging.
“Since NARCAN® Nasal Spray first launched eight years ago, we continue to see today how important this tool is for first responders, law enforcement and, with OTC designation, the general public, to help reduce the number of opioid overdose deaths occurring each day,” said Paul Williams, SVP and products business head at Emergent. “Extending the expiration date of NARCAN® Nasal Spray to four years is an example of our ongoing collaboration with the FDA and commitment to ensure customers and patients are equipped with this life-saving medicine in response to such a devastating public health crisis.”
The opioid epidemic is one of the country’s biggest public health issues. Recent Centers for Disease Control and Prevention (CDC) data show over 105,000 Americans died of a drug overdose during the 12-month period from August 2022 to August 2023, of which eight in 10 deaths were opioid related.
In August 2023, Emergent announced the OTC availability of NARCAN® Nasal Spray to help broaden access and save lives against opioid overdose emergencies. For more information, visit NARCAN.com.
About NARCAN® Nasal Spray
NARCAN® Naloxone HCl Nasal Spray 4 mg is the first FDA-approved, over-the-counter (OTC) 4 mg naloxone product for the emergency treatment of opioid overdose. NARCAN® Nasal Spray is not a substitute for emergency medical care. Repeat dosing may be necessary. Use as directed.
About Emergent BioSolutions
At Emergent, our mission is to protect and enhance life. For 25 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we plan to protect or enhance 1 billion lives by 2030, visit our website and follow us on LinkedIn, X (formerly Twitter), and Instagram.
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Investor Contact:
Richard S. Lindahl
Executive Vice President, CFO
lindahlr@ebsi.com
Media Contact:
Assal Hellmer
Vice President, Communications
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