FDA Approves Naloxone for Over-the-Counter Use

Regulatory agencies have taken many steps recently to remove barriers and increase access to Naloxone — one of our most important tools to battle the opioid epidemic.

What is Naloxone?

Naloxone is an opioid blocker or antagonist that prevents opioid molecules from bonding to opioid receptors in cells. When taken, it will block opioids from having effects on the body. The U.S. Food and Drug Administration (FDA) first approved the medication in 2015 for the initial treatment of opioid overdose in emergent life-threatening situations.

FDA Approval

On March 29th, 2023, the FDA announced the approval of Narcan® (Naloxone) 4 mg nasal spray for over-the-counter use. Previously, it was only available with a prescription. This is now the only Naloxone product available over-the-counter, as other formulations remain prescription only.

To gain approval as over-the-counter status, drug manufacturers have to show that the over-the-counter formulations are safe and effective when used as directed with updated labeling. They also have to demonstrate that patients can safely use the medication without the direct supervision of healthcare professionals.

Availability 

It is unclear how long it will take until these products are available for purchase without a prescription, as the exact timing of the launch will depend on the manufacturers. The FDA states that it may take many months before the product is available on store shelves. Because of this, pricing information for over-the-counter Narcan® is not yet known.

CorVel’s Clinical Team Input

The FDA’s decision to transition Naloxone nasal spray from a prescription-only product to an over-the-counter medication will likely save many lives. While opioid use continues to decrease in the workers’ compensation patient population, the dangerous opioid epidemic still exists and impacts many patients. This approval is a welcome step in increasing access to critical, potentially life-saving medications. 

CorVel has included Naloxone nasal sprays and injections on the standard workers’ compensation formulary for a while now. Payments occur once in a 365-day period in conjunction with opioid usage on the injury claim. Many states have also started requiring the co-prescribing of Naloxone products with opioid use. CorVel’s pharmacy team monitors Naloxone usage and collaborates with claims professionals to identify claims with fill activity.

This FDA approval was a critical step taken to promote patient safety. We will continue monitoring claim activity and manufacturers’ updates about potential launch dates for these products. They, too, will be formulary medications. Based on industry trends, it is also expected that over-the-counter Narcan® will be more cost-effective than the prescription-only ones that are currently available. 

To read the FDA’s full press release statement, click here.