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2023-03-30| Trials & Approvals

Emergent BioSolutions’ Over-The-Counter Naloxone Nasal Spray Receives FDA Greenlight

by Joy Lin
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Emergent BioSolutions has announced the US FDA approval of Narcan, a 4mg naloxone hydrochloride nasal spray for over-the-counter (OTC) use. The nod makes Narcan the first naloxone product to not require a prescription. 

Narcan’s expanded access to the public comes as the US grapples with an ongoing opioid epidemic. According to estimates from the Centers for Disease Control and Prevention (CDC), around 110,000 people died from opioid overdoses in the US last year, largely due to the spread of illegal fentanyl.  

Narcan Being the First OTC Naloxone Product

The Narcan nasal spray was first approved in 2015 as a prescription medicine for opioid overdose.  Naloxone itself has been approved for use since 1971. 

“The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.

“Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions,” said Cavazzoni. 

Narcan is expected to reach US shelves and at online retailers by the late summer to account for manufacturing changes that support nonprescription packaging as well as changes to the supply chain, said Emergent in a press release. 

Related Article: Walmart To Settle Opioid Lawsuits with $3.1 Billion, U.S. Government Mulls OTC Naloxone

Emergent Reveals Restructuring of Assets

According to a financial report for Q4 2022, Emergent pulled in $91.1 million for its nasal naloxone products, a 24% drop from $120.6 million in the same quarter in 2021. The company has attributed the decrease to a reduction in commercial retail sales following the launch of a generic version of Narcan nasal spray 4mg in December 2021. The decrease has been partially offset by an increase in sales in the US and Canada, the company said. 

Last month, Emergent sold its travel health business to Bavarian Nordic for an upfront $270 million and up to $110 million in sales and development-based milestones. The transaction shed a number of Emergent’s vaccine products, including its investigational chikungunya vaccine CHIKV VLP, as the company revealed a reprioritization of its assets to focus on medical countermeasures and its commercial products, including Narcan. 

The change also saw the company form a new Science and Development function and lay off 132 staff positions, or about 5% of its workforce, in an attempt to save annual costs of over $60 million. 

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