Emergent BioSolutions Receives FDA Approval for OTC NARCAN Nasal Spray New Packaging
Emergent BioSolutions announced that the U.S. Food and Drug Administration, FDA, has approved its supplemental New Drug Application, sNDA, for over-the-counter, OTC, NARCAN Nasal Spray to be packaged in a new carrying case, which includes two blister packs, each enclosed with Quick Start Guide. "Every second counts in an opioid emergency, and our mission at Emergent is to ensure that life-saving tools like OTC NARCAN(R) Nasal Spray are readily available, easily accessible and are second nature to carry," said Paul Williams, senior vice president, head of products business, global government and public affairs at Emergent. "In response to the ongoing opioid overdose epidemic, we believe this new carrying case is an additional option for our customers and consumers to acquire, while encouraging preparedness and expanding accessibility to help save lives."
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- Insider Trading Lawsuit: New York Attorney General Letitia James has sued former CEO Robert G. Kramer for allegedly using nonpublic information to trade Emergent stock in 2020, undermining public trust.
- Settlement Agreement: Emergent has agreed to pay $900,000 in penalties and strengthen executive stock trading controls and policies, demonstrating the company's commitment to compliance and ethical governance.
- Vaccine Production Issues: The lawsuit highlights contamination problems discovered by Emergent in September and October 2020, leading to an FDA order to halt AstraZeneca production in April 2021, which adversely affected the company's production capacity and market reputation.
- Trading Plan Controversy: Kramer’s trading plan, approved in November 2020, allowed him to sell shares in January and February 2021, netting over $10.1 million, illustrating the legal risks associated with executive trading under insider information.

- Insider Trading Allegations: New York Attorney General Letitia James has sued Emergent's former CEO Robert Kramer for insider trading, alleging he executed a trading plan while aware of manufacturing and contamination issues, leading to a 13% drop in the company's stock price.
- Contract Background: Emergent inked a $261 million contract with AstraZeneca in 2020 to produce COVID-19 vaccines, but large quantities were rendered unusable due to contamination, adversely affecting the company's reputation and financial health.
- Fines and Settlement: Emergent agreed to pay $900,000 in penalties as part of a settlement with the Attorney General, while committing to improve executive trading policies to prevent future violations, demonstrating the company's focus on compliance.
- Market Reaction: Despite facing legal challenges, Emergent's stock has gained 15% over the past 12 months, and investor sentiment on Stocktwits shifted from 'bullish' to 'extremely bullish', indicating market confidence in the company's future prospects.

- FDA Approval: Emergent BioSolutions announced that its supplemental New Drug Application for the NARCAN Nasal Spray has been approved by the FDA, with a new carrying case that includes two blister packs, enhancing consumer convenience.
- Increased Market Availability: The new NARCAN packaging will soon be available for purchase nationwide at select retailers and online, as well as through Emergent's NARCANDirect platform for public interest customers, further expanding product accessibility.
- Distribution Milestone: Since the prescription launch of NARCAN Nasal Spray in 2016, over 85 million doses have been distributed across the U.S. and Canada, highlighting the product's significance in addressing the opioid overdose crisis and market demand.
- Public Health Impact: The introduction of the new packaging not only enhances the consumer purchasing experience but may also support public health by improving drug accessibility, helping more individuals respond to overdose situations.
- FDA Approval for New Packaging: Emergent BioSolutions announced that the FDA has approved its supplemental New Drug Application for the NARCAN® Nasal Spray, introducing a carrying case that includes two doses and a Quick Start Guide, aimed at enhancing drug accessibility and portability for emergency use during opioid crises.
- Consumer Demand Insights: A survey by Emergent revealed that 74% of consumers prefer a discreet carrying case, with this preference rising to 81% among college students, indicating a strong market demand for solutions that align with lifestyle needs and potentially increase naloxone usage.
- Importance of Emergency Response: While NARCAN® Nasal Spray can save lives during opioid overdose emergencies, only 10% of consumers currently carry it; the new carrying case design aims to reduce the stigma associated with carrying naloxone, thereby increasing the likelihood of its use in emergencies.
- Market Launch Plans: The NARCAN® carrying case will soon be available for purchase nationwide at select retailers and online, with Emergent aiming to expand public access through its NARCANDirect® platform to address the ongoing opioid overdose crisis.

- Financial Flexibility Boost: Emergent BioSolutions made a $100 million voluntary prepayment on its term loan facility using cash on hand in late December 2025, marking a significant improvement in its financial position and enhancing flexibility for future strategic initiatives.
- Significant Debt Reduction: Since 2023, Emergent has reduced its gross debt by $275 million to a total of $593 million, representing a 32% decline, which strengthens the company's long-term stability as part of its multi-year transformation plan.
- Strategic Plan Advancement: CEO Joe Papa stated that this prepayment not only reflects progress in financial health but also supports the company's mission in public health and its transformation efforts for 2026 and beyond.
- Investor Conference Arrangement: Emergent will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, further showcasing its financial improvements and future strategic direction to attract investor interest.

- Financial Flexibility Boost: Emergent BioSolutions made a $100 million voluntary prepayment on its loan in December 2025 using cash on hand, marking a significant improvement in its financial position and enhancing flexibility for future strategic investments.
- Significant Debt Reduction: Since 2023, Emergent has reduced its total debt by $275 million to $593 million, reflecting a 32% decline as part of its multi-year transformation plan, thereby strengthening long-term stability.
- Strategic Plan Advancement: CEO Joe Papa stated that this prepayment is a crucial milestone in their transformation efforts aimed at driving strategic initiatives in 2026 and beyond, ensuring the company fulfills its mission in public health.
- Investor Conference Arrangement: Emergent will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, further showcasing its financial improvements and future strategic direction to attract investor interest.







