REZENOPY™ (naloxone HCl) Nasal Spray 10 mg

The highest-strength per nasal spray of naloxone available1 for emergency opioid overdose response.

When Seconds Matter, Strength Matters

In the face of increasingly potent synthetic opioids, healthcare providers and emergency responders need tools that match the evolving crisis. REZENOPY™ delivers 10 mg of naloxone HCl in a single intranasal dose. During an opioid overdose, reversing respiratory depression using naloxone products could mean the difference between life and loss.

Healthcare professional wearing blue gloves holding a device of Rezenopy (naloxone HCl) 10 mg nasal spray, with a patient resting in a hospital bed in the background.

Actor portrayal, not actual patient

10 mg REZENOPY™

REZENOPY represents a direct clinical response to the changing landscape of opioid overdoses. While naloxone’s mechanism of action remains unchanged, the concentration matters when facing fentanyl and its analogs.

REZENOPY (naloxone HCl) Nasal Spray 10 mg is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients.1*

*The clinical significance of a higher dose is currently unknown.

Generic Name

Naloxone Hydrochloride
10 mg in 0.11 mL

Dosage Form

Nasal spray

Drug Class

Antidotes

Shelf Life

36 months (3 years) from date of manufacture

Latex-Free

Not made with natural rubber latex

Packaging

Two (2) single-use spray devices per carton (NDC 43674-003-02)

How to Use REZENOPY™

Critical: REZENOPY nasal spray is for intranasal use only. Always seek emergency medical care immediately after administration.1

Administration Instructions2*

  1. Position the patient: Lay the patient on their back. Support the neck with your hand and allow the head to tilt back.
  2. Prepare the device: Insert the nozzle into ONE nostril. Do not prime or test the device before administration.
  3. Administer the dose: Press the plunger firmly to deliver the full dose. Remove the device from the nostril after giving the dose.
  4. Turn and call: Turn the person onto their side. Call 911 or get emergency medical help right away.

Monitor and repeat if needed: If the patient does not respond within 2 to 3 minutes or responds and then relapses while awaiting emergency help, administer another dose into the other nostril using a new device.

Important Administration Notes1

  • Provide additional first aid such as rescue breathing or CPR while awaiting emergency medical assistance if necessary
  • Each device is single-use only—use a new device for each additional dose

*All approved naloxone hydrochloride products achieve plasma concentrations that have been shown to be efficacious in reversing the effects of opioid overdose.

Download the
Quick Start Guide

Screen capture of REZENOPY Quick Start Guide.

Essential administration instructions for emergency situations.

How to Store REZENOPY™

Proper storage ensures REZENOPY is ready when needed most. The medication should be stored at room temperature or in a refrigerator, kept in its original packaging, and protected from light, freezing, and excessive heat.1

Storage Guidelines 1

Temperature

Store between 2°C to 25°C (36°F to 77°F). Brief excursions up to 40°C (104°F) permitted.

Packaging

Keep in original blister and carton until ready to use to protect from light and physical damage.

Accessibility

Keep out of reach of children. Ensure caregivers know where it is stored and how to use it.

Environmental Considerations1

❄️ Do not freeze: If frozen, the device will not spray. If frozen and needed immediately in an emergency, do not wait for it to thaw—get emergency medical help right away.1

🔥Heat exposure: Do not expose to excessive heat above 40°C (104°F). Avoid leaving in vehicles where temperatures can fluctuate widely.

Maintenance and Disposal1

  • Replace the nasal spray before the expiration date printed on the box
  • Always follow the expiration date printed on the blister pack and box
  • Dispose of unused or expired medicine properly by consulting a healthcare professional or pharmacy

Leadership Perspectives

“Our nasal drug delivery team has created a nasal spray that is quick and simple to administer, and which has the potential to prevent unnecessary overdoses across the United States.”

Milton Boyer, CEO, Kindeva Drug Delivery

“The addition of a large national health plan, combined with our GPO agreements covering more than 5,000 institutions, significantly enhances our ability to reach patients, healthcare providers and first responders across the country.”

Narasimhan Mani, President & Co-CEO, Scienture Holdings

“We are excited about this upcoming launch and confident that bringing the highest-strength 10 mg naloxone product to market will address a critical and growing unmet need.”

Shankar Hariharan, Executive Chairman & Co-CEO, Scienture Holdings

“With institutional reach across hospitals, EMS providers and rehabilitation centers, and an expanding commercial team, we are executing on a comprehensive market access strategy designed to maximize awareness, availability and adoption of REZENOPY nationwide. We believe REZENOPY has the potential to become an important tool in the fight against opioid overdose and help expand access to life-saving intervention when every second counts.”

Shankar Hariharan, Executive Chairman & Co-CEO, Scienture Holdings

“REZENOPY represents a significant advancement in overdose response as the highest-strength naloxone available on the market at 10 mg. It is intended for patients who often require multiple doses of lower-strength naloxone for stabilization in emergency situations.”

Narasimhan Mani, President & Co-CEO, Scienture Holdings

About Scienture

Scienture, LLC entered into a definitive agreement with SUMMIT BIOSCIENCES INC. (a wholly owned subsidiary of Kindeva Drug Delivery L.P.) for the exclusive U.S. rights to commercially launch REZENOPY (naloxone HCl) Nasal Spray 10 mg, an opioid antagonist that was approved by the FDA on April 19, 2024.3

REZENOPY is the highest strength per nasal spray of naloxone HCl approved by the FDA. The product leverages the proven use of naloxone hydrochloride and form factor, with increased effectiveness against potent opioids.3

Scienture logo.

References

  1. REZENOPY™ (naloxone HCl) nasal spray 10 mg [prescribing information]. Commack, NY; Scienture, LLC 2025.
  2. REZENOPY™ Quick Start Guide. Commack, NY; Scienture, LLC 2025.
  3. SCIENTURE to commercially launch REZENOPY™, a life-saving opioid overdose emergency treatment through a collaboration with KINDEVA DRUG DELIVERY L.P. Scienture Holdings, Inc. website. Available at: https://scienture.com/newsroom/post?storyId=7035582646038305. Accessed March 2026
  4. SCIENTURE broadens commercial access for REZENOPY™, highest-dose FDA-approved naloxone nasal spray, through GPO agreements reaching over 5,000 U.S. institutions. Scienture Holdings, Inc. website. Available at: https://scienture.com/newsroom/post?storyId=7035582646038305. Accessed March 2026.