The approval, which is for 4 mg naloxone hydrochloride nasal spray, marks the first OTC, nonprescription approval for a naloxone nasal spray and allows the product to be sold directly to consumers in a variety of retail locations well as online.
The US Food and Drug Administration (FDA) has approved 4 mg naloxone hydrochloride nasal spray (Narcan) for nonprescription, over-the-counter (OTC) use.
Announced on March 29, 2023, the approval, which applies only to Narcan nasal spray from Emergent BioSolutions, comes as the country faces an epidemic of drug overdoses claiming more than 100,000 lives annually.
“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” said Robert M. Califf, MD, commissioner of the FDA. “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.”
First approved as a prescription drug in 2015, Narcan nasal spray has become synonymous with ongoing opioid epidemic. Now, with the latest approval, naloxone nasal spray becomes the first naloxone product approved for use without a prescription. According to the FDA, the timeline for availability and price of the OTC version of naloxone hydrochloride nasal spray will be determined by Emergent BioSolutions.
With the approval, the FDA is requiring a change in labeling for the currently approved 4 mg generic naloxone nasal spray products that rely on Narcan as their reference listed drug product. The FDA pointed out manufacturers of these products will be required to submit a supplement to their appreciations to effectively switch their products to OTC status.
As part of the process for receiving a label change from prescription to nonprescription, the manufacturer of naloxone hydrochloride nasal spray, Emergent BioSolutions, was required to provide data demonstrating the drug’s safety and efficacy as directed in its proposed labeling and show consumers can understand how to use the drug without the supervision of a healthcare professional.
“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. “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. 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.”
The approval of OTC naloxone hydrochloride nasal spray comes after the agent was granted priority review status and was placed under the spotlight in an FDA advisory committee meeting in February 2023, which concluded in a unanimous vote to recommend approval for marketing without a prescription. In their announcement, the FDA pointed out the approval may affect the status of other brand-name naloxone nasal spray products of 4 mg or less, but these determinations will be made on a case-by-case basis.