FDA approves first over-the-counter naloxone nasal spray

WASHINGTON (WV News) — The U.S. Food and Drug Administration on Wednesday approved the first over-the-counter naloxone nasal spray.

The agency gave approval for Narcan, 4 milligram naloxone hydrochloride nasal spray for over-the-counter, nonprescription, use. This is the first naloxone product that has been approved for use without a prescription.

Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose.

The approval drew praise from U.S. Sen. Shelley Moore Capito, R-W.Va., who has previously pushed for over-the-counter availability for naloxone.

Last year, she was part of a group of lawmakers who sent letters to several drug manufacturers urging them to apply for over-the-counter status for their respective naloxone products.

"Pleased to see the (FDA) announce approval of first over-the-counter naloxone," Capito said in a tweet Wednesday morning. "It’s never been more important to adopt opioid overdose prevention and reversal strategies on a wide scale."

With West Virginia continuing to deal with the fallout of the opioid crisis, including the prevalence of the synthetic opioid fentanyl, naloxone sprays have become a widespread tool for local law enforcement and other first responders when overdoses are reported.

Efforts by groups like local quick response teams as well as the placement of "ONEbox" boxes on college campuses have worked to make naloxone, and the knowledge of how to properly administer it, available to the general public.

According to an FDA press release, Wednesday's action paves the way for the medication to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.

The timeline for availability and price of the OTC product is determined by the manufacturer. The FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only.

Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl, according to the FDA.

“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 FDA Commissioner Robert M. Califf, M.D.

Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. 

“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, M.D., 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.”