FDA Approves Rextovy, a New Over-the-Counter Naloxone Nasal Spray, Expanding Access to Opioid Overdose Reversal
核心洞察
The FDA approved Rextovy (搜索), a new 4 mg over-the-counter naloxone hydrochloride nasal spray from Amphastar Pharmaceuticals, for emergency opioid overdose (搜索) reversal.
This approval broadens consumer access, allowing purchase without a prescription at pharmacies, convenience stores, and online marketplaces.
U.S. overdose deaths dropped from 111,451 (12 months ending August 2023) to 68,632 (12 months ending December 2025), coinciding with expanded OTC naloxone availability.
The U.S. Food and Drug Administration has approved Rextovy (搜索), a new over-the-counter naloxone hydrochloride nasal spray, marking another significant step in the federal effort to combat the opioid overdose (搜索) crisis. Rextovy, developed by Amphastar Pharmaceuticals, Inc., delivers 4 milligrams of naloxone and is designed for the emergency treatment of known or suspected opioid overdose. With this nonprescription approval, consumers can now purchase Rextovy directly without a prescription at pharmacies, convenience stores, and through online marketplaces.
"Reducing opioid overdose (搜索) deaths is a top priority for FDA," said Mike Davis, M.D., Ph.D., Acting Director of the Center for Drug Evaluation and Research (CDER). "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."
A Shifting Overdose Landscape
The approval arrives against the backdrop of a changing overdose mortality picture. While drug overdose remains a critical public health issue — primarily driven by illicit synthetic opioids like fentanyl — the number of annual overdose deaths in the U.S. has decreased dramatically since the first OTC naloxone nasal spray was approved in 2023. According to FDA data, 111,451 overdose deaths were reported in the 12 months ending in August 2023. By comparison, that figure dropped to 68,632 reported deaths in the 12 months ending in December 2025.
The opioid epidemic continues to be fueled by counterfeit prescription medications. A recent study in Washington, D.C. found that two-thirds of oxycodone tablet samples seized on the street were counterfeit, and 75% of those contained fentanyl — a synthetic opioid 50 to 100 times more potent than morphine.
Expanding Access and Driving Competition
Rextovy (搜索) contains the same active ingredient as previously approved naloxone nasal sprays, including Emergent BioSolutions' Narcan, which became the first OTC naloxone nasal spray following its FDA clearance. Public health officials note that the availability of multiple approved OTC formulations expands consumer choice, encourages market competition that may reduce retail costs, and offers alternative sourcing options for community health groups.
"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," said Karen Murry, M.D., Director of the Office of Nonprescription Drug Products in CDER. "We encourage any manufacturer seeking to market a nonprescription naloxone product to contact the agency to initiate a conversation."
The significance of broad OTC access is underscored by data showing that bystanders were present but unable to provide life-saving measures such as naloxone in approximately 46% of fatal overdoses in the U.S. in 2021. Additionally, retail pharmacies prescribed only around one-third of the roughly 17 million naloxone doses dispensed that year, highlighting gaps that OTC availability aims to close.
Designed for Emergency Use by Untrained Bystanders
Rextovy (搜索) is engineered for administration by individuals without formal medical training. The product's packaging includes prominent pictorial directions outlining five clear steps to facilitate quick action during a high-stress medical emergency. The instructions emphasize that bystanders should call 911 immediately after administering the first dose.
The medication is safe to use even when it is uncertain whether opioids are present in the individual's system. The FDA notes that when a patient regains consciousness following an overdose reversal, they may experience standard opioid withdrawal symptoms, including shaking, sweating, nausea, or irritability.
The approval aligns with federal efforts under the Great American Recovery Initiative, which coordinates the government's approach to prevention, treatment, and long-term recovery to address the nation's addiction and substance use disorder crisis.