FDA Approves Second Over-the-Counter Naloxone Nasal Spray, Rextovy, Expanding Opioid Overdose Access

What this means for your practice

This FDA approval signifies a continued federal commitment to increasing accessibility to life-saving opioid overdose reversal medication. For telehealth brands, medspas, dental practices, chiropractic offices, and other healthcare businesses, this development has several implications. While Rextovy's OTC status means it does not require a prescription from a provider, awareness of its availability is crucial for comprehensive patient care and public health initiatives.

Healthcare providers across specialties, including those in telehealth, should be prepared to discuss the availability and proper use of OTC naloxone with patients, especially those at risk of opioid overdose or with family members who are. This includes patients prescribed opioids for pain management in dental or chiropractic settings, or individuals seeking various health services who may also be impacted by substance use. Integrating this information into patient education, discharge instructions, or wellness discussions can empower patients and their communities to respond effectively to opioid emergencies. Furthermore, the expansion of OTC options can reduce the burden on prescribers for initial access, allowing healthcare professionals to focus on comprehensive treatment and prevention strategies, while ensuring patients know where and how to obtain this critical intervention.

WASHINGTON D.C. — The U.S. Food and Drug Administration (FDA) announced on June 16, 2026, the approval of Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray, for over-the-counter (OTC) sale. This marks the second OTC naloxone nasal spray approval, significantly broadening consumer access to this critical emergency treatment for opioid overdose.

The Regulatory Action

With this approval, consumers can now directly purchase Rextovy without a prescription from various retail locations, including pharmacies, convenience stores, and online platforms. This initiative is a core component of federal efforts, such as President Trump’s Great American Recovery Initiative, aimed at addressing the persistent addiction and substance use disorder crisis in the United States.

Mike Davis M.D., Ph.D., Acting Director of the Center for Drug Evaluation and Research (CDER) at the FDA, emphasized the agency's commitment to reducing opioid overdose deaths. “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,” Dr. Davis stated.

Impact on Public Health

Naloxone is a medication known for its ability to rapidly reverse the effects of opioid overdose. It serves as the standard emergency treatment for such events. Rextovy contains the same active ingredient as other approved naloxone nasal sprays, providing another life-saving option available directly to consumers. The availability of multiple approved formulations is expected to expand market availability, foster competition that may lead to reduced costs, and offer alternative sourcing options for consumers.

The FDA highlighted that while the number of overdose deaths has substantially decreased since the first OTC naloxone nasal spray approval in 2023, drug overdose remains a significant public health issue, largely driven by synthetic opioids like illicit fentanyl. The agency reported 111,451 overdose deaths in the 12-month period ending in August 2023, which decreased to 68,632 in the 12-month period ending in December 2025, underscoring the ongoing need for accessible interventions.

Karen Murry, M.D., Director of the Office of Nonprescription Drug Products in CDER, reiterated the FDA’s dedication to ensuring widespread availability of nonprescription options. “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,” Dr. Murry noted.

Product Details and Safety

Rextovy is designed for ease of use, featuring packaging with pictorial directions outlining five clear steps, including the crucial instruction to call 911 after administering the first dose. It is safe for use even when there is uncertainty regarding the presence of opioids in an individual's system. While using Rextovy, some individuals may experience symptoms upon regaining consciousness following overdose reversal, such as shaking, sweating, nausea, or feelings of anger.

The nonprescription approval for Rextovy was granted to Amphastar Pharmaceuticals, Inc.

This regulatory action represents a significant step in the ongoing battle against the opioid crisis, equipping more individuals with the tools to save lives in emergency situations.

Key Facts

| Detail | Value | |---|---| | Approval Date | June 16, 2026 | | Product Name | Rextovy | | Dosage | 4 milligram (mg) naloxone hydrochloride nasal spray | | Availability | Over-the-counter (OTC) without a prescription | | Manufacturer | Amphastar Pharmaceuticals, Inc. | | Public Health Impact | Aims to reduce opioid overdose deaths; 68,632 overdose deaths reported in the 12-month period ending December 2025 |

Frequently Asked Questions

What is Rextovy?

Rextovy is a 4 milligram (mg) naloxone hydrochloride nasal spray approved by the FDA for the emergency treatment of opioid overdose.

Where can consumers purchase Rextovy?

Consumers may directly purchase Rextovy without a prescription in places such as pharmacies, convenience stores, and online.

What is the significance of this FDA approval?

This approval broadens access to another over-the-counter option for naloxone, empowering people without medical training to take immediate action to reverse opioid overdoses, which has been proven to save lives. It also aligns with federal efforts to address the U.S.’ addiction and substance use disorder crisis.

Are there any side effects when using Rextovy?

When using Rextovy, some people may experience symptoms when they regain consciousness following overdose reversal, such as shaking, sweating, nausea, or feeling angry.

Is it safe to use Rextovy if I'm unsure if someone is experiencing an opioid overdose?

Yes, Rextovy is safe to use even when it is uncertain whether opioids are present in the person’s system.

Source: FDA — FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose · Tue, 16 Jun 2026 08:41:20 EDT