Gaithersburg’s Emergent BioSolutions Reports FDA Advisory Committees’ Unanimous Vote in Favor of NARCAN Nasal Spray for Over-The-Counter Use

If approved by the FDA, NARCAN Nasal Spray will be the first 4 mg naloxone nasal spray switched from prescription status to over-the-counter use

Gaithersburg-based Emergent BioSolutions announced the U.S. Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committeehave unanimously voted in favor (a total of 19 votes) that the benefit-risk profile of NARCAN^®(naloxone HCl) Nasal Spray is supportive of its use as a nonprescription opioid overdose reversal agent. Emergent presented an overview of its over-the-counter (OTC) development program, the medical need, Human Factors study data and seven years of post-marketing safety data. The FDA is not bound by the committees’ guidance but will take its advice into consideration.

“This favorable recommendation marks another important step forward to broaden access to NARCAN Nasal Spray for those who may be at risk of an opioid overdose,” said Paul Williams, SVP and Products Business Head, Emergent BioSolutions. “Today’s vote reaffirms our confidence in the safe and effective use of NARCAN in the community setting. We want to thank the participants in the open public hearing who shared their insights and personal experiences informing the need to make NARCAN more readily available over the counter.”

According to the United States Centers for Disease Control and Prevention, more than 107,000 Americans lost their lives to a drug overdose in 2021, of which more than 70,000 were a result of using synthetic opioids containing fentanyl.¹ The rise in opioid-related deaths, including the increase associated with use of fentanyl, specifically during the COVID-19 pandemic, has prioritized the need to expand access to opioid overdose reversal treatment.

“Bystanders are present at nearly half of fatal overdoses, yet naloxone is administered in only a small percentage of those cases,” ² said Dr. Joshua Lynch, Clinical Associate Professor of Emergency and Addiction Medicine, University at Buffalo Jacobs School of Medicine and Biomedical Sciences. “The reality is accidental overdoses can happen to anyone, anywhere, at any time, and we can all do our part by being prepared to help like we would in any other emergency. With access to over-the-counter naloxone, we would have a critical opportunity to close this gap and reduce the number of opioid-related deaths.”

Emergent was the first company to submit a supplemental New Drug Application for OTC and received Priority Review by the FDA. If approved, NARCAN would be the first 4 mg naloxone nasal spray available OTC in the U.S. The Prescription Drug User Fee Act goal date is March 29, 2023. Emergent will continue to work with policymakers, retailers, advocates and other stakeholders to help ensure policies and solutions are implemented to increase access and awareness of this potentially lifesaving medicine.

INDICATION AND IMPORTANT SAFETY INFORMATION

What is NARCAN Nasal Spray?

• NARCAN Nasal Spray is a prescription medicine used for the emergency treatment of a known or suspected opioid overdose emergency with signs of breathing problems and severe sleepiness or not being able to respond.
• NARCAN 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 NARCAN Nasal Spray, even if the person wakes up.

NARCAN Nasal Spray is safe and effective in children for known or suspected opioid overdose.

Who should not use NARCAN Nasal Spray?

Do not use NARCAN Nasal Spray if you are allergic to naloxone hydrochloride or any of the ingredients in NARCAN Nasal Spray.

What is the most important information I should know about NARCAN Nasal Spray? NARCAN Nasal Spray is used to temporarily reverse the effects of opioid medicines. The medicine in NARCAN Nasal Spray has no effect in people who are not taking opioid medicines. Always carry NARCAN Nasal Spray with you in case of an opioid overdose.

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