What To Know About The FDA’s Approval Of OTC Narcan

In recent years, drug overdose deaths in the United States have skyrocketed, primarily due to synthetic opioids like fentanyl. Studies show we can greatly reduce these deaths by increasing access to Narcan.

Narcan is the brand name for a life-saving medication called naloxone. This prescription drug can quickly reverse an opioid overdose. 

On March 29th, 2023, the Food and Drug Administration (FDA) approved an over-the-counter (OTC) version of Narcan. Here’s what you should know about this decision. 

The History Of Narcan

Narcan is a nasal spray formulation of naloxone. The FDA approved it in 2015. Before then, naloxone was only available in an injectable formulation, which the FDA approved in 1971. 

Like injectable naloxone, Narcan was introduced as a prescription-only drug. It could only be prescribed by healthcare providers or administered by first responders. 

However, by 2022, all 50 states had enacted laws, standing orders, or other arrangements that allowed people to get Narcan from certain pharmacies without a prescription. In addition, harm reduction programs throughout the country have been distributing free Narcan for years. 

Even so, many people have struggled to access OTC Narcan, often due to issues finding a local pharmacy or harm reduction program that offers the drug. 

Other people have avoided asking their pharmacists about the drug or visiting harm reduction programs due to a fear of judgment. Also, some people might not even know Narcan is available over-the-counter since it has been marketed exclusively as a prescription drug.

The FDA’s Approval Of OTC Narcan

The FDA’s approval of OTC Narcan will significantly increase access to the medication. It’s an essential step toward reducing overdose deaths and ending the opioid crisis. 

When Will OTC Narcan Be Available?

According to the drug’s manufacturer, Emergent BioSolutions, OTC Narcan will be widely available by late summer 2023. 

The drug will appear in many more pharmacies than it currently does, as well as grocery stores, convenience stores, and gas stations. It will also be sold online and possibly even in vending machines.

How Much Will OTC Narcan Cost?

The approved product includes two doses of Narcan that contain 4 milligrams each. By prescription, this product costs about $70. The FDA has not yet announced whether the OTC version will cost the same. 

If you can’t afford OTC Narcan, you can still get the drug for free from a harm reduction program. You can find local harm reduction programs offering Narcan here. 

Why Approve OTC Narcan Now?

The FDA has been preparing to approve OTC Narcan for several years. 

In 2019, the agency announced that it had designed a model naloxone Drug Facts Label (DFL) with easy-to-understand instructions on administering the drug. This announcement was meant to encourage drug manufacturers to seek approval for OTC naloxone products.

In November 2022, the FDA announced a preliminary assessment that some naloxone products, including Narcan nasal spray, are safe and effective for OTC use. In February 2023, an FDA advisory committee voted unanimously to recommend the approval of OTC Narcan nasal spray.

Who Should Get Narcan?

Anyone who uses opioids or loves someone who does should consider getting Narcan. 

You should also consider getting the drug if you or someone you love uses illegal drugs (including non-opioids). 

This is because many illegal drug manufacturers lace their products with fentanyl. Fentanyl is a synthetic opioid that’s up to 50 times stronger than heroin. It has been linked to numerous overdose deaths. 

How To Administer Narcan

When administering Narcan, it’s important to follow the instructions that came with your specific product. 

In general, you start by holding the nasal spray with your thumb on the bottom of the plunger and two fingers on either side of the nozzle. You then tilt the person’s head back and use your hand to provide support under the neck. 

Next, you gently insert the tip of the nozzle in one of the person’s nostrils until your fingers touch the bottom of the person’s nose. You then press the plunger firmly to release the dose. If the person does not respond within 2 minutes, administer another dose. 

You should also call 911 if you have not already done so.

Narcan can be safely administered to people of all ages. 

When Should You Administer Narcan?

You should administer Narcan to anyone experiencing symptoms of an opioid overdose. These symptoms include:

• pale, clammy, or bluish skin
• bluish fingernails and/or lips
• gurgling noises
• nausea and vomiting
• slowed or stopped breathing
• slowed or stopped heartbeat
• loss of consciousness

Sometimes, you might not know whether the person used an opioid or a different type of drug. In that case, you should still administer Narcan. It won’t have any effect (positive or negative) on a person who has not used opioids. 

Opioid Addiction Treatment

While Narcan is life-saving, it does not treat opioid use disorder (also called opioid addiction). If you or someone you love feels unable to stop using opioids (or any other type of drug), seek help at an addiction treatment program. When left untreated, addiction often leads to a fatal overdose. 

To learn more about addiction treatment, please reach out to an Ark Behavioral Health specialist. Our inpatient and outpatient treatment programs offer personalized, evidence-based care to keep you or your loved one healthy.