Emergent Applauds Availability of Over-the-Counter Naloxone in U.S. House of Representatives

GAITHERSBURG, Md., July 28, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announces its recognition of the U.S. House of Representatives for adding over-the-counter (OTC) naloxone to every AED location in its buildings, providing direct access to first responders and anyone coming across an individual who may be experiencing an opioid overdose. This effort has been led by Representative Buddy Carter (R-GA), with his team and congressional constituents, who have kept this public health issue a priority.

Expanding access to potentially life-saving treatments is critical to saving more Americans and their families from an opioid overdose death. Emergent remains focused on saving lives through efforts to increase access, awareness and the availability of NARCAN^® Nasal Spray 4 mg and KLOXXADO^® Nasal Spray 8 mg. Emergent strives to engage with key stakeholders committed to reducing overdose deaths, as one death is one too many.

“The efforts of Representative Carter (R-GA) to make naloxone readily available in the U.S. House of Representatives are commendable, and we are pleased to recognize his work to help save a life during an opioid overdose emergency,” said Joe Papa, president and chief executive officer at Emergent. “We believe the over-the-counter availability of naloxone, including our product, NARCAN^® Nasal Spray, has directly contributed to the reduction in overdose deaths reported by the U.S. Centers for Disease Control and Prevention. Measures like this reinforce the importance of having life-saving naloxone nearby as an opioid overdose can happen to anyone, anywhere and at any time.”

In 2023, Emergent launched NARCAN^® Nasal Spray as the first OTC opioid overdose reversal treatment. With more than 85 million doses distributed in the U.S. and Canada since 2016, it is an important tool in helping save lives from opioid overdose, including those caused by fentanyl. Emergent is the leading U.S. supplier of nasal naloxone, and offers an expanded range of products to support public interest groups, workplaces/businesses, as well as patients, consumers and healthcare providers.

• NARCAN^® (naloxone HCl) Nasal Spray 4 mg (two-dose carton)
• NARCAN^® Nasal Spray Wall Unit Kit: includes wall unit cabinet with alarm, poster and wayfinder sign
• KLOXXADO^® (naloxone HCl) Nasal Spray 8 mg (two-dose carton)
• Convenience Kits: includes medical grade components including: One hard case with internal pockets, one medical grade CPR mask, one pair of nitrile examination gloves

Visit or one of Emergent’s product sites,  and  to learn how to be prepared in an opioid overdose emergency with life-saving intranasal naloxone.

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.

Important Safety Information for KLOXXADO^® (naloxone HCl) Nasal Spray 8 mg

What is KLOXXADO^® Nasal Spray?

• KLOXXADO^® Nasal Spray is a prescription medicine used for the treatment of an opioid emergency such as an overdose or a possible opioid overdose in adults and children with signs of breathing problems and severe sleepiness or not being able to respond.
• KLOXXADO^® Nasal Spray is to be given right away and does not take the place of emergency medical care.
• Get emergency medical help right away after giving the first dose of KLOXXADO^® Nasal Spray, even if the person wakes up.
  
  

What is the most important information I should know about KLOXXADO^® Nasal Spray?

Get emergency medical help right away after giving the first dose of KLOXXADO^® Nasal Spray. The signs and symptoms of an opioid emergency can return after KLOXXADO^® Nasal Spray is given. If this happens, give another dose after 2 to 3 minutes using a new KLOXXADO^® Nasal Spray and watch the person closely until emergency help is received.

The medicine in KLOXXADO^® Nasal Spray is safe to use in people who are not taking opioids. KLOXXADO^® Nasal Spray is not intended for self-administration.

What should I tell my healthcare provider (pharmacist or prescriber) before using KLOXXADO^® Nasal Spray?

Before using KLOXXADO^® Nasal Spray, tell your healthcare provider about all of your medical conditions, including if you:

• have heart problems
• are pregnant or plan to become pregnant. Use of KLOXXADO^® Nasal Spray may cause withdrawal symptoms in your unborn baby. Your unborn baby should be examined by a healthcare provider right away after you use KLOXXADO^® Nasal Spray.
• are breastfeeding or plan to breastfeed. It is not known if KLOXXADO^® Nasal Spray passes into your breast milk.
  
  

What are the possible serious side effects of KLOXXADO^® Nasal Spray?

KLOXXADO^® Nasal Spray may cause sudden opioid withdrawal symptoms including body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramping, weakness, and increased blood pressure.

In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include seizures, crying more than usual, and increased reflexes.

Who should not use KLOXXADO^® Nasal Spray?

Do not use KLOXXADO^® Nasal Spray if you are allergic to naloxone hydrochloride or

any of the ingredients in KLOXXADO^® Nasal Spray.

What are the most common side effects of KLOXXADO^® nasal spray?

The most common side effects of KLOXXADO^® Nasal Spray in adults include stomach-area (abdomen) pain, weakness, dizziness, headache, nose (nasal) discomfort, and a feeling like you are going to faint.

These are not all of the possible side effects of KLOXXADO^® Nasal Spray. Please see , including Patient Information, which includes a more complete discussion of the risks associated with KLOXXADO^® Nasal Spray. Always contact your healthcare provider (pharmacist or prescriber) if you have questions or experience any side effects.

You are encouraged to report negative side effects to the FDA at: 1-800-FDA-1088 or . You can also contact Hikma Specialty USA Inc. at: or call 1-877-845-0689 or 1-800-962-8364.

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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  and follow us on , , ,  and . 

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Richard S. Lindahl

Executive Vice President, CFO

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Vice President, Communications