FDA has approved Amphastar’s Rextovy, a 4 mg naloxone nasal spray, for OTC use, expanding access to overdose reversal medication amid ongoing opioid crisis.
Written By: Meghana Jinka, PharmD
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration (FDA) has approved Amphastar Pharmaceuticals’ Rextovy, a 4 mg naloxone hydrochloride nasal spray, for over-the-counter (OTC) use in the emergency treatment of opioid overdose. The approval allows consumers to purchase the product without a prescription through pharmacies, convenience stores, and online retailers, expanding access to a standard treatment for opioid overdose.
The decision adds another FDA-approved naloxone formulation to the U.S. market and supports broader efforts to improve access to overdose reversal medications. Increased availability may strengthen supply chains, expand consumer choice, and encourage market competition that could help reduce costs.
FDA officials emphasized that reducing opioid overdose deaths remains a public health priority. “Expanding OTC naloxone options gives consumers additional access to a proven intervention that can save lives during overdose emergencies,” said Mike Davis, M.D., Ph.D., Acting Director of the FDA’s Center for Drug Evaluation and Research (CDER).
Clinical Importance of Naloxone
Naloxone is an opioid antagonist that rapidly displaces opioids from receptors in the brain, reversing respiratory depression and other potentially fatal effects of overdose. It remains the standard emergency treatment for opioid toxicity and a cornerstone of public health efforts to reduce overdose-related deaths.
The active ingredient in Rextovy is the same naloxone used in other FDA-approved nasal spray products. Importantly, naloxone can be administered even when opioid involvement is uncertain, making it a critical first-response intervention in suspected overdose situations.
Regulatory Review and Safety Information
FDA based the nonprescription approval on studies showing consumers could understand the product’s labeling, recognize when naloxone should be administered, and use the nasal spray correctly without healthcare professional assistance.
Rextovy includes illustrated instructions outlining five administration steps, including a recommendation to call emergency services immediately after the first dose is given.
As with other naloxone products, some individuals may experience opioid withdrawal-related symptoms after overdose reversal. Reported reactions can include shaking, sweating, nausea, irritability, and anger as consciousness returns. The product can be safely administered even when it is unclear whether opioids are present in a person’s system.
Public Health Context
The approval comes as overdose deaths in the United States continue to decline but remain at historically elevated levels. According to federal data cited by the FDA, overdose deaths fell from 111,451 during the 12-month period ending August 2023 to 68,632 during the 12-month period ending December 2025.
Despite the decline, illicit fentanyl and other synthetic opioids remain the primary drivers of overdose deaths in the United States, underscoring the continued need for rapid access to overdose reversal medications.
“Immediate access to naloxone remains essential during overdose emergencies,” said Karen Murry, M.D., Director of the Office of Nonprescription Drug Products within CDER, reaffirming the agency’s commitment to expanding nonprescription availability.
Implications for Opioid Overdose Response
The approval adds another FDA-authorized nonprescription naloxone option as public health agencies continue expanding community access to overdose reversal medications. Greater product availability may improve emergency preparedness in homes, schools, workplaces, and other high-risk settings.
With Rextovy now available for OTC sale, Amphastar joins a growing market of nonprescription naloxone manufacturers supporting broader efforts to reduce opioid-related mortality across the United States.
Reference
FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose | FDA
About the Writer
Meghana Jinka (LinkedIn) is a Pharm.D graduate with a strong interest in clinical pharmacy, clinical research, pharmacovigilance, and medical writing. She has developed expertise in evaluating scientific literature, interpreting clinical data, and communicating complex medical information in a clear and accessible manner. Through clinical training, patient counseling, and healthcare awareness activities, she has gained practical experience in evidence-based medicine and patient-centered care. Passionate about healthcare communication, Meghana is committed to developing accurate, engaging, and evidence-based healthcare documents that support healthcare professionals and the wider community.