The U.S. Food and Drug Administration approved a new over-the-counter naloxone nasal spray on Tuesday in an effort to combat the nation’s opioid overdose crisis.
Rextovy is a naloxone hydrochloride nasal spray that can be used for the emergency treatment of opioid overdoses, according to the FDA. The approval “aligns with President Donald Trump’s Great American Recovery Initiative, a federal effort to address the U.S.’ addiction and substance use disorder crisis and coordinate the government’s approach to prevention, treatment and long-term recovery,” an FDA spokesperson told the Daily Caller News Foundation.
“Reducing opioid overdose deaths is a top priority for FDA,” Acting Director of the FDA’s Center for Drug Evaluation and Research (CDER) Mike Davis said in a statement. “Today’s approval of an additional over-the-counter naloxone nasal spray helps broaden access and offers an additional option for consumers. Empowering people without medical training to take immediate action with these products has been proven to save lives.”
There were an estimated 69,973 drug overdose deaths across the U.S. in 2025, marking a decrease of nearly 14% from the 81,313 deaths in 2024, according to the Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics. Overdose deaths involving opioids declined from an estimated 55,296 in 2024 to 44,564 in 2025.
“Immediate access to naloxone nasal sprays is essential when a person is experiencing an overdose, and FDA remains committed to ensuring nonprescription options are widely available,” Director of the CDER’s Office of Nonprescription Drug Products Karen Murry said in a statement. “We are proud of the dedicated work our review divisions put into making this approval possible, and we encourage any manufacturer seeking to market a nonprescription naloxone product to contact the agency to initiate a conversation.”
The FDA announced it had approved naloxone hydrochloride nasal spray Narcan for over-the-counter, nonprescription use in March 2023. Narcan was initially approved by the FDA in 2015 as a prescription drug.
The White House Office of National Drug Control Policy unveiled the Trump administration’s statement of “Drug Policy Priorities” in April 2025, which is a “comprehensive and coordinated blueprint to reduce the devastating impact of illicit drugs on American society.”
“The Statement lays out the urgent, first-year steps that must be taken to address the scourge of illicit drug use that continues plaguing our nation and taking American lives,” according to the news release. “The implementation of these priorities will complement President Trump’s tireless efforts to stop Foreign Terrorist Organizations, cartels, and drug traffickers from harming Americans, and will help build a safer, healthier future for America.”
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