FDA Approval for Emergent BioSolutions’ OTC Narcan Breaths New Hope in the Battle Against Opioid Overdoses
By Alex Keown
March 29, 2023
The FDA greenlit an over-the-counter version of Emergent BioSolutions’ Narcan nasal spray for the emergency treatment of opioid overdose. The approval marks the first prescription strength naloxone nasal spray to receive over-the-counter status in the U.S.
The priority review approval of the OTC version follows a deadly year in the nation’s opioid epidemic. Data from the Centers for Disease Control and Prevention indicate approximately 110,236 people died in the United States from an opioid overdose. Many of those deaths were driven by the increased availability of illegal fentanyl. In 2021, More than 107,000 Americans lost their lives to a drug overdose.
It is estimated that there is an opioid-related death every eight minutes in the United States, a situation that is expected to worsen due to the increased use of synthetic opioids, Emergent BioSolutions noted in its announcement.
Robert G. Kramer, president and chief executive officer of Emergent BioSolutions, called the FDA’s approval of the OTC Narcan a historic milestone in the battle against opioid addiction.
“We have delivered on our commitment to make this important emergency treatment widely accessible, given the alarming rates of opioid overdoses occurring across the country,” Kramer said in a statement.
For Emergent BioSolutions, the approval of OTC Narcan comes two months after the company initiated organizational changes within the company to enhance its core medical countermeasure business, which includes vaccines for anthrax and smallpox.
This prescription-to-OTC approval was supported by Human Factors study data, an updated Drug Facts label, pharmacovigilance data collected from various public sources. The new OTC product will have the same formulation, device design, and original prescription strength, Emergent noted in its announcement. These are important features and benefits to help counteract the effects of opioids, including fentanyl, the company added.
With the approval, Kramer said Emergent will work with representatives from the government, retail and advocacy groups to ensure availability of the newly-approved OTC product. The Gaithersburg-based company anticipates over-the-counter availability by late summer of this year. Over the next several months the company will implement manufacturing changes related to the OTC status, as well as supply chain modifications, Emergent announced.
Until the OTC products are available, Emergent noted the prescription version will remain available for pharmacies across the nation.
Narcan nasal spray first received approval from the FDA in 2015. In February, the FDA’s Nonprescription Drugs Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee unanimously supported approval of an OTC version of Narcan.
“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price,” FDA Commissioner Robert M. Califf said in a statement.
Since its approval, more than 44 million doses of Narcan have been distributed in the United States.
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Alex Keown is a freelance journalist who writes about a variety of subjects including the pharma, biotech, and life science industries. Prior to freelancing, Alex has served as a staff writer and editor for several publications.
