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Emergent BioSolutions Receives U.S. FDA Approval of Supplemental New Drug Application (sNDA) for NARCAN® Nasal Spray Multipacks

Emergent BioSolutions

Fri, February 13, 2026 at 8:00 AM GMT+9 4 min read

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EBS

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Emergent BioSolutions

_Approval will broaden the NARCAN® Nasal Spray portfolio, and improve cost-effectiveness by_ _increasing flexibility and distribution efficiency of this life-saving medication _  

GAITHERSBURG, Md., Feb. 12, 2026 (GLOBE NEWSWIRE) – Today, Emergent BioSolutions (NYSE: EBS) announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for new multipack configurations of over-the-counter (OTC) NARCAN® Nasal Spray. This approval expands the NARCAN® Nasal Spray product suite to include 6-count and 24-count multipack options, specifically designed to meet the needs of partners distributing higher volumes of naloxone. These new formats offer enhanced flexibility with the same trusted product, benefiting community programs and organizations operating large-scale, multi-site, or high-volume distribution programs.

“At Emergent, we work closely with our partners to develop solutions that help improve delivery, distribution and accessibility of NARCAN® Nasal Spray,” said Paul Williams, senior vice president, head of products business, global government & public affairs at Emergent. “The introduction of NARCAN® Nasal Spray multipacks marks a significant step in empowering our partners on the front lines. They can now better streamline bulk distribution, support broad preparedness efforts, and ultimately ensure that more communities and individuals have ready access to this life-saving medication in the event of an opioid overdose emergency.”

This approval builds on Emergent’s ongoing commitment to enhancing NARCAN® Nasal Spray accessibility and usability, complementing the recent FDA approval of the NARCAN® Nasal Spray Carrying Case in January 2026. These efforts underscore Emergent’s comprehensive approach to equipping individuals and organizations with effective tools to combat opioid overdose deaths. The 6-count and 24-count multipacks will be made available soon to purchase for public interest customers through NARCANDirect®, Emergent’s proprietary ordering and distribution platform. These multipacks are an addition to the current portfolio and will not replace existing product formats. Since the prescription launch of NARCAN® Nasal Spray in 2016, more than 85 million doses have been distributed across the U.S. and Canada. Visit NARCAN.com and ReadytoRescue.com to learn more.

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.

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**About Emergent BioSolutions

**At Emergent, our mission is to protect and save lives. For over 25 years, we’ve been at work preparing those entrusted with protecting public health. We deliver protective and life-saving solutions for health threats like smallpox, mpox, botulism, Ebola, anthrax and opioid overdose emergencies. To learn more about how we help prepare communities around the world for today’s health challenges and tomorrow’s threats, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify.

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, are forward-looking statements. We generally identify forward-looking statements by using words like “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “goal,” “intend,” “may,” “plan,” “position,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on our current intentions, beliefs and expectations regarding future events based on information that is currently available. We cannot guarantee that any forward-looking statement will be accurate. Readers should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by any forward-looking statements. Readers should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the U.S. Securities and Exchange Commission, when evaluating our forward-looking statements.

Investor Contact:
Richard S. Lindahl
Executive Vice President, CFO
[email protected]

Media Contact:
Assal Hellmer
Vice President, Communications
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