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FDA approves first over-the-counter naloxone nasal spray

May 2, 2023 · Clinical Team

On March 29, 2023, the U.S. Food and Drug Administration (FDA) approved Narcan® (naloxone hydrochloride) 4 mg Nasal Spray for over-the-counter (OTC), nonprescription, use. This is the first naloxone product to be approved for OTC use, which will result in expanded access to this life-saving medication. Naloxone rapidly reverses the adverse effects of opioid analgesics in an overdose.

Emergent BioSolutions Inc. received FDA approval for the OTC version of Narcan Nasal Spray. Emergent stated in a press release that the nasal spray will be available on U.S. shelves and at online retailers by the late summer. This timing will allow for implementation of OTC nonprescription packaging, instructions, and supply chain modifications. In the meantime, naloxone (for example, nasal spray, injectable) remains available by prescription, through standing orders, and community distribution. 

Impact on workers’ compensation and auto no-fault

According to treatment guidelines, naloxone nasal spray and naloxone injectable are considered first-line treatment options when naloxone is necessary. For this reason, both prescription and OTC formulations of naloxone nasal spray (for example, Narcan Nasal Spray, Kloxxado® Nasal Spray) are allowed on our formularies where the use of opioid analgesics may be appropriate, including the global workers’ compensation, auto, and standard injury-based formularies. 

Impact on Optum Settlement Solutions clients

The Centers for Medicare and Medicaid Services (CMS) allocates naloxone products for opioid overdose reversal at one unit (syringe or nasal spray device) per year. In reference to Workers’ Compensation Medicare Set Asides (WCMSAs), naloxone nasal spray will be dual designation with prescription and OTC versions.  Naloxone would qualify under Medicare Part D and be included in a WCMSA if used in prescription format.    Overall, the exposure for naloxone nasal spray in a WCMSA is not significant. The WCMSA cost allocated per year is noted below:

Medication name NDC Quantity AWP*
Narcan 4 mg /0.1 ml nasal spray (brand-name) 69547-0353-02 1 $75.00
Naloxone 4 mg/0.1 ml nasal spray (generic) 45802-0811-84 1 $64.80

Please note that RED BOOK® AWP is subject to change

We will continue to keep the industry informed as further information is available.

If you have any questions, please contact your account manager, clinical liaison, or our Clinical Services team at 1-877-275-7674 ext. 8612.


  1. FDA Press Release - FDA Approves First Over-the-Counter Naloxone Nasal Spray | FDA. Accessed on March 31, 2023.
  2. Emergent BioSolutions Press release U.S. FDA Approves Over-the-Counter Designation for Emergent BioSolutions’ NARCAN® Nasal Spray, a Historic Milestone for the Opioid Overdose Emergency Treatment – Emergent BioSolutions. Accessed on March 31, 2023.
  3. IBM Micromedex® RED BOOK® [database online]. Truven Health Analytics®, an IBM Company. Accessed on March 31, 2023.
  4. WCMSA Reference Guide – WCMSA Reference Guide Version 3.8. Accessed March 31, 2023.
  5. ODG by MCG Treatment Guidelines [database online]. An MCG Health Company. Accessed on April 3, 2023.

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